Device and method for temporary or permanent suspension of an implantable scaffolding containing an orifice for placement of a prosthetic or bio-prosthetic valve

ABSTRACT

In a surgical method for improving cardiac function, an implantable scaffold or valve support device is inserted inside a patient&#39;s heart and attached to the heart in a region adjacent to a natural mitral or other heart valve. The scaffold or valve support device defines an orifice and, after the attaching of the scaffold or valve support device to the heart, or temporary support while native valve leaflets and/or subvalvular structures are captured, a prosthetic or bio-prosthetic valve seated in the orifice, and the native valve may be retracted into the scaffold/replacement assembly to create a gasket for sealing the complex.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/798,629 filed Apr. 8, 2010 and claiming the benefit of U.S.Provisional Patent Application No. 61/168,279 filed Apr. 10, 2009. Thisapplication also claims the benefit of U.S. Provisional PatentApplication No. 61/439,734 filed Feb. 4, 2011 and the benefit of U.S.Provisional Patent Application No. 61/518,772 filed May 11, 2011.

FIELD OF THE INVENTION

The present invention relates to medical devices and procedures, inparticular related to the fixation within the heart or blood vessel of adevice which enables replacement of a heart valve, and moreparticularly, to a novel device for use in a novel procedure forperforming a catheter-based heart valve replacement.

BACKGROUND OF THE INVENTION

The four valves of the human heart consist of either two or threepliable leaflets attached circumferentially to a fibrous skeletalannulus. Normally, heart valves function to open in one portion of thecardiac cycle, either systole or diastole, (depending on the valve),causing minimal resistance to forward blood flow, but close by hingingfrom the annulus during the other part of the cardiac cycle, with theleaflets (either two or three) coming into central contact with eachother, such that retrograde flow is inhibited.

Heart valve regurgitation, or leakage occurs when the leaflets of thevalve fail to come fully into contact. This can be congenital, or theresult of a disease process. Regardless of the cause, the leakageinterferes with heart function, since it allows the unintended flow ofblood back through the valve. Depending on the degree of leakage, thebackward flow can become a self-destructive influence on not onlyfunction, but also cardiac geometry. Alternatively, abnormal cardiacgeometry can cause the leakage, and the two processes are “cooperative”in causing acceleration of abnormal cardiac function.

The result of a valve having significant regurgitation is that apathological state develops in which blood may be simultaneously pumpedboth forward through the outflow valve of a chamber and backward throughthe inflow valve, decreasing forward cardiac output. Depending on theseverity of the leakage, the capability and efficiency of the heart topump adequate blood flow can be compromised. In the case of the twotrio-ventricular valves, (the mitral and tricuspid), the process can becaused by myocardial infarction damaging papillary muscles located inthe left (or right) ventricle, torn or abnormally elongated chordaetendineae, or in any valve through damaged valve structures byinfection, degenerative processes, or stretching of the annulus suchthat leaflets no longer come into contact by virtue of the increasedcross-sectional area. Stretching of the ventricle and increased distancebetween the papillary muscles can also cause leakage of theatrio-ventricular (A/V) valves.

At present, for the most part, regurgitant valves can be eithersurgically repaired or replaced, both currently requiring open-heartsurgery, use of cardio-pulmonary bypass and stoppage of the heart.Because of the magnitude of the procedure, risk of death, stroke, andbleeding, respiratory, renal, and other complications is significantenough that many patients are not candidates for treatment. The heart oraorta must be cut open, and even when performed by very experiencedsurgeons, repairs can fail early, or, if initially successful, are notalways durable over time.

In the case of the mitral valve, replacement with a prosthetic orbio-prosthetic valve is associated with a higher operative mortalitythan repair of the native valve, but does not result in recurrentregurgitation experienced after a repair. The higher mortality isthought to be the result of loss of the function of the papillarymuscles of the left ventricle, which are attached to the mitral valveleaflets by cords known as chordae tendineae, which contribute totethering of the leaflets and systolic shortening of the left ventricle.However, with preservation of these sub-valvular structures, theoutcomes equalize, or may be better in severe cases with replacement andsub-valvular structure preservation. (See Ann Thorac Surg 2 81:1153-61.)

Even though the prognosis of surgically untreated mitral regurgitationis poor, (see N Engl J Med 2 352:875-83), only 33% of patients withsignificant regurgitation are referred, due to age, co-morbidities, orphysician preference (see European Journal of Cardio-thoracic Surgery 34(2) 935-936).

In the face of a severe, life threatening pathological process with notreatment offered to a majority of patients due to the magnitude of therisks of currently available therapy, a simpler, less invasive approachto treatment, such as a percutaneous device that can effectivelyeliminate regurgitation, yet preserve annulo-ventricular inatrio-ventricular connectivity and function, is severely needed.

For this reason, there is widespread development currently underway forplacement of valves into the aortic (see Circulation December 2002 p.3006-3008), and Pulmonary, (see J. Am. Coll. Card., vol. 39, May 15,2002, p. 1664-1669), positions. There are currently a variety oftechnologies for aortic replacement, but all generally have anexpandable support structure for attached pliable leaflets, deliveredeither through the apex of the ventricle or retrograde through the aortafrom the femoral artery (The Journal of Thoracic and CardiovascularSurgery; October 2008, p 817-819).

Because of the asymmetry of the annuli, as well as the lack of rigidity,the same principals cannot be applied to the mitral and tricuspidvalves, or in the aortic valve in the absence of calcification, as inmost cases of aortic insufficiency. In the mitral position, severalapproaches have been pursued. Additionally, in the case of the mitralvalve, radial expansion of a prosthetic replacement could impinge on theaortic valve, with which it shares a portion of its annulus along theanterior mitral leaflet.

Primarily, remodeling or alteration (to support or decrease the size) ofthe mitral annulus by various means has been a focus of intenseinterest. Some of the most tested of these are those that rely on theperceived anatomic proximity between the posterior annulus and thecoronary sinus (see Webb, et al). Although initially promising, thecoronary sinus has been shown in virtually all cases to course on theatrial side of the mitral annular plane, and averages 7 to 11 mm fromthe annulus, and the distances are variable. Moreover, the distancesincrease in subjects with mitral regurgitation. (See Choure, et al, JAm. Coll. Card.; Vol. 48, No. 10, 2.) The approach has been largelyabandoned.

Another approach is the central apposition of the anterior and posteriorleaflets at the midpoint, mimicking the so-called “Alfieri stitch”. Thebenefit comes from creation of central coaptation. Devices to createthis reconfiguration have been tested and commercialized, but do notcontrol regurgitation to the degree achieved in replacement.

In general, current heart valve replacement procedures generally requireinvasive surgery. This, of course, is a long, difficult and complexprocess and requires that the patient endure significant, invasivesurgery. While various alternatives have been proposed to minimize thistrauma, there is still a need in the art to further reduce suchpotential injury.

SUMMARY OF THE INVENTION

Recently a number of prosthetic valve-replacement devices have beendeveloped that can be delivered through a trans-catheter approach, andthat expand into the natural annulus of a native valve. Since themechanism of fixation of these valves is generally radial expansion,either actively or passively, a rigid annulus, (such as withcalcification or a previously placed surgical valve or ring), isrequired, or the replacement valve would distort, or even rupture theheart. In many cases of valve pathology, the disease process does notinclude a rigid annulus or fibrous skeleton of the heart. Consequently,the benefit of these advances is limited to specific pathologicalstates.

Proof of the concept has been published in the medical literature in avery similar way. Inelastic rings were surgically implanted adjacent tothe native mitral valve of sheep. One week later, percutaneous valveswere successfully expanded into the rings in all five animals. (SeeJournal of the American College od Cardiology, Vol. 58, No. 24, 2011.)The current invention enables the implantation of the ring, orneo-annulus, through a catheter.

U.S. Patent Application Publication No. 2010/0262232 and InternationalPatent Application No. PCT/US2010/001077 describe an implantablescaffold that contains a neo-annulus into which a prosthetic orbio-prosthetic valve could be implanted. The present invention seeks toprovide a means through which that scaffold, which is rigid, can beinserted such that the radially expanding, trans-catheter valve conceptcan be extended to valves with pathology not currently amenable to thisapproach.

In a surgical method for improving cardiac function in accordance withthe present invention, an implantable scaffold or valve support deviceis inserted inside a patient's heart (or blood vessel) and attached in aregion adjacent to a natural or native valve. In the heart, the scaffoldor valve support may be anchored to the heart wall and/or to the nativevalve itself. The scaffold or valve support device defines an orificewhich receives a prosthetic or bio-prosthetic valve after disposition ofthe scaffold or support device in the heart and either before or afteranchoring of the scaffold or support to the heart.

A catheter is placed into the appropriate location, and the scaffoldassembly is delivered out the tip of the catheter. The scaffold ispositioned in part by steering the delivery catheter and in part bymanipulating tethers or wires that are removably attached to thescaffold. The wires may be flexible, steerable, or relatively stiff, andmay be pre-formed or made of a component with a memory. In oneembodiment of the invention, through use of specific fixation methodsand devices disclosed herein, the scaffold is then fixed at its marginor body to a heart or blood vessel wall adjacent to a native valve. Insequence, the scaffold is delivered, positioned, and then fixed to theheart or blood vessel wall. With the scaffold or heart valve supportsystem in place, a prosthetic valve can be installed in an annulus oraperture of the scaffold. In an alternative approach described herein,after the scaffold is ejected from the distal end of the deliverycatheter into a heart chamber and expanded from a collapsed insertionconfiguration to an expanded deployment configuration, a prostheticvalve is seated in an orifice of the scaffold and the combined assemblyis attached, through use of specific fixation methods and devicesdisclosed herein, to the leaflets or the subvalvular apparatus of thenative valve.

In the case of AV valves, the scaffold or valve support device is atleast indirectly secured to chordae tendineae, and therefore, thepapillary muscles of the heart. Such a device can distribute forces tothe prosthetic valve similar to those typical of the normal, nativevalve. Thus, the attached or entrained chordae tendineae serve to retainthe scaffold and prosthetic valve in position in opposition to systolicblood pressure. The current invention involves in part a method and anassociated device for capturing the natural valve and concomitantly andindirectly the subvalvular apparatus and incorporating those structuresinto the scaffold or heart valve support system, or to the prostheticvalve.

Where the native valve is captured and coupled to a combinedscaffold/replacement valve assembly, the scaffold and the replacementvalve mounted thereto are attached to the leaflets of a native valve sothat the scaffold and the replacement valve are in fluid-sealingengagement with the leaflets. Closure devices may be provided to closecommissure gaps, if necessary.

During the implantation procedure, the valve-supporting scaffold may beattached to the heart chamber or vessel wall via at least one but morepreferably a plurality of flexible or rigid tensile suspensionelement(s) or alternatively the scaffold may be held in place by tethersor other supporting elements extending from a delivery or deploymentcatheter. In either instance, the scaffold or neo-annulus, or theassembly of the combined replacement valve and scaffold or neo-annulus,are attached to the native valve, such that all forces normally borne bythe native valve, and to which the replacement valve is now subjected,are transmitted to the native valve, and its subvalvular apparatus, inthe case of atrio-ventricular valves.

A scaffold or neo-annulus in accordance with the present invention, ifemployed in a setting wherein attachment of the valve directly into theannulus of a native heart valve is not ideal, possible, or otherwisefeasible, enables valve placement wherein it otherwise could not occur,yet maintains the normal transmission of forces from the replacementvalve to the native valve. The present invention provides devices andmechanisms for fixation of the suspension elements to the heart orvessel wall, as well as devices and mechanisms for incorporation of thesub-valvular apparatus, in the case of atrio-ventricular valves, (or tothe native valve in the case of ventricular outflow valves), to theimplanted scaffold or neo-annulus.

Fixation of Neo-annulus Suspension Elements to Heart or Blood VesselWall

Deployment of a replacement valve through a trans-catheter approachrequires first that there is a stable, inelastic valve support scaffoldwith an orifice into which the replacement valve can be inserted.Stability can be achieved through fixation of such a valve supportscaffold to the heart or blood vessel wall. In this embodiment, theprocess requires first that the scaffold or valve support device besuspended or supported. This scaffold-like element defines, in oneembodiment, of an orifice into which the valve will ultimately bedeployed, which is suspended by one or a plurality of structuralelements of the device, which fixes it to a heart or blood vessel wall.

Therefore, the neo-annulus scaffold may be actively suspended from theheart or blood vessel wall through the use of one or more suspensionelements, each an elongate flexible tensile element. The suspensionelement(s) may be actively or automatically affixed to the heart orblood vessel wall. In the case of active attachment, the suspensionelement(s) may each be provided with a deployment tether that extendsthrough the deployment catheter to a site of proposed fixation on thesuspension element to the heart or blood vessel wall (for example, theend of suspension component remote from its attachment the neo-annulus).With the neo-annulus supported in its desired location, the end of thesuspension element is advanced to the proposed site of fixation on theheart or blood vessel wall, and a helical or alternatively-shaped,screw-type fixation or similar component or a pronged staple or otherfixation element is used to secure the suspension element to the heartor blood vessel wall.

Once the appropriate locus for fixation of the suspension component(s)on the heart or blood vessel wall has been reached, the tethers used todeliver fixation device(s) to the suspension element(s) may be used bothto create fixation and to manipulate/position the suspension element(s).By advancement of the fixation device(s) over the tether(s), a means isprovided whereby manipulation of fixation elements and placement of theelements in a specific location in the heart or blood vessel wall.Fixation of the suspension element(s), once achieved, provides supportfor the neo-annulus, because of its connection to the heart or bloodvessel wall by (an) intervening member(s), which is (are) the suspensionelement(s).

The attachment, or fixation, of a suspension element to the heart orblood vessel wall may be made by a separate component, such as a staple,clip or device of other appropriate design delivered by a separatecomponent, or may be an integral part of the suspension element itself,such as a burr, barb, hook, or other appropriate fixation element. Ingeneral, the suspension elements are likely to be sigmoid or somewhatlinear structures, extending radially from the orifice-definingneo-annulus scaffold to the point of attachment to the heart or bloodvessel wall.

The suspension element or elements are generally part of theconstruction of, or attached to, the scaffold or neo-annulus as a whole,and are attached or otherwise fixed to the scaffold, extending to theheart or blood vessel wall, wherein the suspension element(s) areattached. However, the suspension elements may be separate structuresand be delivered and attached to the neo-annulus in-situ. The suspensionelements may be of any length, so that the neo-annulus may be somewhatdistant, very near, of even essentially in contact with the walladjacent to the valve or annulus.

In one embodiment, the orifice-defining neo-annulus scaffold preferablytakes the form of a ring. The ring made be made of nitinol or othershape-memory material with a temperature induced memory or other meansby which the scaffold assumes a substantially rigid, or at leastinelastic configuration of pre-determined shape after ejection from thedelivery or deployment catheter. Alternatively, it may be passivelyexpanded and be made of another appropriate material, such as a weave,fabric, or monofilament material. The scaffold is optionally providedwith the above-described linear suspension components, which areextendible outwardly to attach to the heart or blood vessel wall nearthe native valve for which replacement is intended. The suspensionelements may be of any length or shape, and may appear like spider legs,or as ring-topped, flattened tripod (in in instance wherein three suchelements are used). They are constructed preferably of a spring-likematerial and are curved to allow for fixation to a heart or blood vesselwall of variable contour, as well as for excursion of the neo-annulustoward or away from the valve as necessary, but may be in anyappropriate configuration.

The suspension components or “legs” are, in an especially preferredembodiment, permanently attached/constructed to the valve-support ring,but are of a material and design that allows them to assume a folded orcollapsed configuration within the delivery catheter. The suspensionelements may be actively extended by deployment tethers operated fromoutside the subject or automatically extended, in the case of aspring-like material, when released. Also, the suspension elements mayeither be actively guided toward, or designed in a way as to extendautomatically to, the heart or blood vessel wall, wherein fixation ofthe ends of the suspension elements to the heart or blood vessel wallwill ensue. Alternatively they may be actively deployed, as by balloonexpansion or other method.

In the passive-fixation iteration of the device, each of the one or moresuspension elements has a barb, hook or other appropriate fixationelement at its free end. Apposition of the hook, barb, or otherappropriate fixation element to the heart or blood vessel wall resultsin attachment of the respective suspension element to the heart or bloodvessel wall. This automatic attachment may be by an expansion orpiercing or other passive fixation element. The suspension elements areeach configured to passively connected to the heart or blood vesselwall. In the most preferred iteration, the hook, barb, burr, or otherappropriate component is manipulated by a tether or other similarcomponent of the suspension capable of the manipulation/engagement, butamenable to subsequent removal. This could occur through release of aself-expansile suspension element that engages and attaches to the heartor blood vessel wall as it expands, as in the case of an expanding metalor other memory-like material that expands when released and pierces theheart or blood vessel wall.

With the neo-annulus located adjacent to the native valve, allowing freeflow through its center, and fixation to the heart or blood vessel walladjacent to the native heart valve, the valve replacement processrequires deployment of the valve, and simultaneous or subsequent captureof the native valve and fixation to the neo-annulus/replacement valvecomplex. In both iterations, the valve-capture tension elements areincorporated into the neo-annulus so as to transmit forces generated bycardiac function to the neo-annulus, and the tethers run over or nearthe tension elements to allow a “push-pull” on the neo-annulus relativeto the native valve.

The orifice, which is more or less central to the device, is generallycircular or becomes generally circular, and is defined by an inelasticscaffold or neo-annulus into which a replacement valve can be deployed,the scaffold or neo-annulus being deliverable through a deliverycatheter placed at an appropriate position in a heart chamber or bloodvessel through a percutaneous, trans-vascular approach.

Therefore, the valve-supporting scaffold is flexible and capable ofbeing collapsed, folded, twisted, or otherwise compressed that it canassume a low profile for delivery but becomes a generally round orotherwise appropriate configuration after delivery. The scaffold orneo-annulus may be reconfigured passively or automatically, for example,by being made of a temperature-sensitive or non-temperature sensitiveshape memory material that reconstitutes when liberated from acompressed or folded state. Alternatively, reformation into anappropriately round shape may be active, such as by placement of acentral expansile element, such as an inflatable balloon, that activelycreates a round orifice or central neo-annulus before deployment of areplacement valve.

In one embodiment, the orifice-defining neo-annulus scaffold preferablytakes the form of a ring. The ring made be made of nitinol with atemperature induced memory by which the scaffold, having been deliveredin a flexible configuration, assumes a substantially rigid configurationof pre-determined shape after ejection from the delivery or deploymentcatheter. The scaffold is optionally provided with the above-describedlinear suspension components, which are extendible radially, orgenerally in an outward direction, to attach to the heart or bloodvessel wall near the native valve for which replacement is intended. Thesuspension elements appear like spider legs, or as ring-topped,flattened tripod (in in instance wherein three such elements are used),or other appropriate configuration. They are constructed preferably of aspring-like material and are curved to allow for fixation to a heart orblood vessel wall of variable contour, and allow for excursion of theneo-annulus toward or away from the valve as necessary.

Since most replacement valves are deployed by radial expansion, theorifice or neo-annulus is preferably flexible for at least a given timeafter ejection from the delivery catheter, so as to allow manipulationand reconfiguration after delivery, but also relatively inelastic sothat a radially expanded valve does not distort it. The valve-supportingscaffold or neo-annulus may therefore be constructed of a braided ormonofilament metal or other appropriate synthetic or naturally occurringmaterial with the appropriate physical characteristics.

The scaffold or heart valve support device is thus delivered through acatheter in a collapsed configuration, and so is compressible orotherwise reconfigurable to fit into the lumen of a delivery catheter.After delivery through the tip of a delivery catheter, the scaffolddevice is be suspended and fixed in a position adjacent to a heart valvefor which replacement is considered, and into which a valve cansubsequently be placed.

Suspension element(s), as well as the neo-annulus, may be covered orcoated with a substance to enhance tissue ingrowth, prevent clot orblood adhesion, may be drug eluting, have heparin or other substancebonding, or or otherwise be constructed of a material that enhancestissue ingrowth, prevent clot or blood adhesion, or other propertiesdeemed to be advantageous.

After suspension by the elements, attachment to the native valveleaflets and replacement valve deployment follow essentially asdisclosed hereafter.

Stabilization of Neo-annulus Through Temporary Support Through DeliveryCatheter Prior to Capture of Native Vale/Subvalvular Apparatus, WithoutFixation to Heart or Blood Vessel Wall

Deployment of a replacement valve through a trans-catheter approachrequires first that there is a stable, rigid or inelastic neo-annulus,or orifice, into which the replacement valve can be inserted. Stabilitycan be achieved through temporary support of the neo-annulus or orificewithout permanent fixation to the heart or blood vessel wall.

In this approach, the valve-receiving scaffold is suspended through orby the delivery system while the valve is deployed and the native valveleaflets are incorporated into the neo-annulus or replacement valve.Thereafter, since fixation of the neo-annulus and replacement valvedeployed therein to the native heart valve or subvalvular apparatus iscompletely supportive of the implanted devices, the connection to andsupport from the delivery system may be interrupted and thereplacement-valve/neo-annulus left in situ, with forces on thereplacement valve being transferred to the native valve (and thesubvalvular apparatus, in the case of A/V valves), wherein they areborne in the normal or natural physiological state.

In this embodiment, the neo-annulus may be suspended by a single tetheror a plurality of tethers (preferably three or four) that allow bothsupport and positional maneuvering of the neo-annulus. The tethers areremovable when the need for support no longer exists. Thus theneo-annulus is deployed via the delivery system connected to thetethers, and after either actively or passively expanding, is positionedand supported over the orifice of the targeted native valve. Mostpreferably, the tethers are placed over or near tensile couplingelements having free or distal ends adapted to entrain, capture, andgrasp native valve leaflets. The tethers are slidable relative to thetension/tensile coupling elements and engage the neo-annulus or scaffoldso as to enable the operator to push the scaffold in a distal directionwhile holding or pulling on the tensile coupling elements, therebyapproximating the scaffold (typically with replacement valve mountedthereto) and the leaflets of the native valve.

Regardless of the support/suspension strategy (suspension elements ortemporary support through the delivery system), the suspendedneo-annulus is supported at least in part by the positioning tethersthat pass over the tensile coupling elements. The tensile couplingelements pass through or otherwise are incorporated into the substanceof the neo-annulus. On the distal ends of the tension elements aredevices for capturing and entraining the native valve leaflets, toretract the native valve leaflets and bring them into contact or nearcontact with the neo-annulus.

The devices for valve leaflet capture are hooks (e.g., grappling hooks),barbs, clips, burrs, or other appropriate entrainment components thatallow adherence/fixation of the tension elements to the valve leafletswhile still allowing their normal or near normal excursion. Thus, untilengaged, valve leaflets have continued “normal” (or with no or minimaladditional impediment), or near normal function until such time as theyare captured and tethered/incorporated into the neo-annulus/replacementvalve complex by simultaneous “forward” or distally (in the direction offorward blood flow) directed force on the tethers and retracting forceon the tension elements within or near the tethers.

The hooks, barbs, clips, burrs, or other appropriate components maypenetrate, impinge, entrap, clip over, or in any other appropriate wayengage the leaflet so as to allow tension to be placed permanentlythereon by traction elements to which the hooks, barbs, burrs, or otherappropriate components are attached. Since the tension elements areincorporated into an aspect of the neo-annulus or central orifice, thevalve leaflets may be pulled into contact with the neo-annulus orcentral orifice.

To create the excursion of the neo-annulus with its orifice toward thenative valve leaflets in a preferred embodiment, the tension members areretracted or pulled in a proximal direction from the proximal end (i.e.,outside of the body) as the tethers, generally tubular memberssurrounding portions of the tension members, are advanced in a distaldirection from the proximal end of the delivery catheter. The opposingforces cause the valve-supporting neo-annulus or scaffold with itsvalve-receiving orifice to move toward the native valve. In general,since this excursion may also disrupt native valvular function, it iscontemplated that the replacement valve will have been deployed into thecentral orifice of the neo-annulus or scaffold before the finalapproximation excursion is generated.

It is possible for the neo-annulus to be delivered through a catheterpassed directly through the heart wall. In the case of the A/V valves,entry may be made through a ventricle and the neo-annulus suspendedproximal to the valve on the atrial side. In that approach, the supportof the valve or sub-valvular structures is achieved from the ventricularside, reversing the above-discussed neo-annulus seating and supportingprocedure. In order to approximate a valve support member or scaffoldand the leaflets of a native valve to one another in a trans-ventricleprocedure, the scaffold or valve support member may be pulled in theproximal direction (towards to operating surgeon) while the valveleaflets are held or pushed in the distal direction. In any event,forces are exerted on the scaffold and the valve leaflets so as to movethe scaffold or valve support member on the one hand and the valveleaflets on the other hand towards one another and intoforce-transmitting and effective fluid-sealing contact.

To permanently position the replacement-valve/scaffold complex in afluid-sealing engagement with the valve leaflets, the tension or tensilecoupling elements preferably have a “lock” such as a one-way incrementalmovement device in the nature of a ratchet. The ratchet may take theform of cooperating tooth formations and a tapered passageway or springloaded latch, a cam, a compression device or other appropriate componentthat prevents the valve-supporting neo-annulus or scaffold member frommoving away from the native valve, once having moved toward it. The lockmay be built into the neo-annulus or scaffold, or be a separatecomponent, advanced over the tension element toward the neo-annulus orcentral orifice.

Once the neo-annulus/replacement valve complex has become fixed to thenative valve, creating a seal, the neo-annulus is supported by thenative valve leaflets. The neo-annulus or scaffold may be additionallysupported by tensile suspension elements attached to the cardio-vascularwall, particularly in the event that such suspension elements are usedto hold the neo-annulus or scaffold in place during the implantationprocedure.

After the securing of the neo-annulus or scaffold to the native valveleaflets, positioning tethers can be removed, as well as proximalportions of the tensile coupling elements, The distal end portions ofthe tensile coupling elements remain in place holding the neo-annulus tothe native valve leaflets in tension, the final position of theneo-annulus or scaffold being secured through the “lock” mechanism.

It is possible that after restriction/capture of the valve leaflets, theneo-annulus/captured valve contact will not completely eliminate leakagearound the valve. In one embodiment of an implantation system inaccordance with the invention, an inflatable or otherwise expandablecomponent such as an annular bladder can be enlarged around theneo-annulus to further inhibit paravalvular leak and enhance the sealbetween the native valve and the scaffold/replacement valve. Thissealing component may initially take the form of a collapsedinner-tube-like component that is attached to the neo-annulus or that isseparately delivered and positioned in situ. The inflatable sealingcomponent is provided with an inflation tube through which air, salinesolution, another fluid, or other appropriate substance, such aspolymers, is infused, expanding the sealing component to eliminatepotential or actual peri-valvular leak. After expansion of the sealingcomponent, the inflation tube is removed/plugged, or otherwiseeliminated from permanent connection with the inflatable sealingcomponent. Also, a fluid, such as saline, may be initially infused, butlater be exchanged for another, potentially permanent material, such asa polymer or other material of appropriate properties.

In addition to acting as a means of resolving perivalvular leakage, thecircumferential or partially circumferential inflatable component may beused simply as a means to make the apposition of native valve andneo-annulus less erosive, less distorting to the heart, more likely tofit a rigid neo-annulus/replacement valve complex into a generally soft,beating heart without long-term tissue change, or other potentiallydesirable characteristics. In essence, the inflatable component mayimpart the characteristics of a “sewing ring” such as is found on mostvalves constructed for open surgical implantation.

The inflatable sealing component may be delivered as a separate element,or be a part of the construct of the central orifice or neo-annulus. Itmay be constructed of an elastic material or one of fixed volume and/orshape, regardless of the pressure of its internal contents. It may befilled with fluid long-term, or have a permanent polymer that can beinfused primarily, or as a replacement for an initial fluid or gasinfusate. It may be covered or coated with a substance to enhance tissueingrowth, prevent clot or blood adhesion, may be drug eluting, heparinor other substance bonding, or otherwise be constructed of a materialthat enhances tissue ingrowth, prevent clot or blood adhesion

Alternatively, an implantable clip, barb, staple or other approximationdevice of appropriate design may be placed at the site of a gap betweennative valve leaflets for bringing the leaflets into apposition aroundthe scaffold or valve support device to obliterate a site ofperivalvular leakage. One such device for perforating two nearby tissuestrictures has a multi-pronged or multiply legged “V”, “U”, “Y”structure or other similarly shaped component, such that afterperforation of the generally two, or paired, barbs on the clip into thetissue structures, advancing the clip in one direction (in the examplesdescribed, upward) the perforation sites are brought into apposition.

Such a clip-like approximation device is constructed of a metallic orother appropriate material, may have memory, and are placed andmanipulated through the delivery system or other means. It is affixed inplace, as with bending the arms outward, automatically springing whenreleased, fixation with a separate element, or other appropriate means.Alternatively, a spring-like device, suture-like device, staple-likedevice, or other means of apposing native valve leaflets at gaps may beused.

The leaflet approximation device may be introduced prior to introductionof the remainder of the implantable devices, creating a smaller orificein the native valve, and enabling a potentially more completecircumferentially solid line of contact between theneo-annulus/replacement valve complex. Therefore the capture of thenative valve, introduction of the scaffold, deployment of thereplacement valve may follow apposition of the commissures, in order todiminish the size of the native vale orifice.

In general, in the implantation embodiment wherein the neo-annulus isonly temporarily supported by the delivery system while permanentfixation to the native valve is achieved (or if suspended by eitherelongate elements, as disclosed above, or by a membranous componentdisclosed previously, and after suspension has been accomplished), theplacement of the scaffold and replacement valve may consist of aprocedure summarized as follows:

-   -   A delivery system is inserted through the vascular system or        heart wall to an appropriate site in a heart chamber or blood        vessel near a valve to be replaced.    -   A device consisting of the tensile coupling elements for valve        capture, the neo-annulus, suspension elements, if appropriate,        support tethers, and other components, as required, is advanced        out of the delivery system.    -   The valve leaflets are engaged by the tensile coupling elements        incorporated into or attached to the neo-annulus. In some        iterations, where a heart wall is used for introduction, these        tensile elements may be compressive.    -   The neo-annulus is suspended to the heart or blood vessel wall        if appropriate, or alternatively, supported only by tethers        emanating from the delivery system.    -   The replacement valve is deployed into the neo-annulus.    -   The native valve is retracted by the tensile coupling elements        with entrainment or capture components on their ends, such that        the retracted leaflets form a “gasket”-like element toward or        around the perimeter of the replacement valve/neo-annulus        complex, eliminating leak and retracting the native valve out of        the inflow or outflow tract to or from the native valve.        Separate or incorporated locking devices integrated with the        tension elements cause a “one-way” tightening of the tension        elements, so that the leaflets are retracted into the        neo-annulus/replacement valve complex.    -   The inflatable element, if used, is inflated to eliminate        peri-valvular leakage. The initial inflation substance can then        be replaced if appropriate, and imaging confirms elimination of        peri-valvular leak. Alternatively, a hook, barb, clip, or other        device of appropriate design is placed into adjacent native        valve leaflets at the site of a gap, such that valve leaflets        are apposed.    -   Tethers, tubes, extensions of tension elements are finally        removed, leaving only the replacement valve, neo-annulus, and        inflatable component or gap-closure device, if used. Any other        appendages associated with delivery, deployment, stabilization,        fixation, valve capture, inflation, etc. are removed.    -   As an alternative, the commissures may be apposed prior to the        implementation of the above sequence.

Capture of the Native Valve

With certain valves in the heart, specifically the atrio-ventricularvalves, the sub-valvular structures are important for chamber function.It has been recommended, therefore, when replacement is performed ratherthan repair, that these structures be incorporated into the annulus ofthe new valve. (See M. A. Borger, et al Ann Thoracic Surg 2006;81:1153-1161.) The current invention provides a device and method forincorporation of these structures into the scaffolding, therebypreserving ventriculo-annular contribution to systolic function.

Accordingly, the current invention also contemplates a device and meansfor attachment of the native valve, or sub-valvular structures (in thecase of the mitral or tricuspid valves) to either the neo-annulus oranother part of the implanted scaffold. In the principal embodiment,attachment elements consist of single or multiple hooks, single ormultiple barbs, or other appropriate means of grasping the valveleaflet(s) or chordae tendineae, and attaching them either directly orwith an intervening element to some portion of the scaffold, such that,in the case of the atrio-ventricular (A/V) valves, systolic ventricularforces on a valve implanted into the neo-annulus will be transmitted tothe papillary muscles and cords rather than to the fixation points ofthe scaffold margin alone, thus preserving systolic A/Vvalvular/papillary function.

In a particularly preferred embodiment, the valve leaflets are “snagged”by one or more hooks or barbs. As discussed above, a device withmultiple hooks is incorporated, through tensile or compressive couplingmembers, into the neo-annulus, and is delivered through the native valveorifice during the entrainment process by bringing the neo-annulustoward the leaflets or subvalvular structures. The hooked device may beadvanced through a catheter and across the native valve orifice prior toemergence through the delivery system of the neo-annulus and suspensionelements, if used, or advanced from the ventricle, in the case where atransmural (across a heart wall) approach is used. In other words, thevalve capture elements may be first out of the delivery system, followedby the neo-annulus, followed by the suspension elements, if used, or thelast, depending on the direction of deployment and delivery. In thisway, minimal delivery system size may be possible. Other sequences ofdelivery are possible.

The hooks, barbs, clips, or other appropriate components attached to thetensile coupling elements may precede the delivery of the remainder ofthe scaffold out of the delivery catheter. The hooks, barbs, clips, orother appropriate components may have one or more separate deliverycomponents, which enable the capture of the leaflets. The hooks, barbs,clips, or other appropriate components are removably or temporarilyattached to the delivery or deployment device, which may advance thehooks or barbs out of the catheter and into the valve orifice as notedabove. In a preferred approach, the hooks may “snap” into a deliveryelement, or may be freely advanced through a native valve, and arepassed from a delivery catheter through the valve orifice, betweenleaflets. The delivery element may have the capability of manipulatingthe location on the native valve wherein the hooks, barbs, clips, orother appropriate components are engaged to the native valve.

Alternatively, the delivery catheter may cross the native valve, deliverthe hooks, barbs, burrs, or other valve capture elements, then retractback across the native valve before releasing the neo-annulus and othercomponents.

The deployment elements may then orient the hooks or barbs, andsubsequently release them once the leaflets were engaged by the hooks orbarbs. The tensile coupling elements on the hooks may be used to furthermanipulate the hooks or barbs, such as twisting or applying tension toincrease or maintain purchase of the hook or barb on the leaflet.

In a preferred embodiment, tension or tensile members attached to thehooks or barbs used to capture the valve leaflets may be permanentlyattached to or through a retention element of the scaffold orneo-annulus, generally at outer edge, so as to facilitate the appositionof the native valve around the edge of the neo-annulus/replacement valvecomplex. Alternatively, the elements may be secondarily attached to theneo-annulus or scaffold.

Because the coaptation surface of some valves is linear, while thereplacement or prosthetic valve to be placed is round, it may bedesirable to have the hooks or barbs dispersed or spread around theperimeter of the neo-annulus/replacement valve complex. In the mostpreferred embodiment, the tension/tensile members are preferablydistributed at intervals around the neo-annulus. Alternatively, they maybe spread separately after exiting from their connection to the centralorifice on neo-annulus.

Therefore, there may be a feature of the deployment element that fansout or separates the hooks or barbs as they leave the delivery catheter.Such a device element may consist of a released spring, elasticmaterial, pre-shaped memory substances, active opening, or otherappropriate means of dispersing or separating the hooks or barbs over alength of valve leaflet before attachment of the valve-grasping elementto the scaffold or valve support system.

In order to assist in the delivery of the valve-capture elements, whichare hooks, barbs, or other appropriate elements designed to engage thenative valve leaflets, the hooks, barbs, or other appropriate elementsmay be collapsed or otherwise constrained into a lower profileconfiguration. This enhances delivery and minimizes native-valvefunctional disruption prior to fixation to the native valve, replacementvalve deployment, and native valve capture. As such, the hooks, clips,barbs, or other appropriate elements may be actively configured into alow profile, as when bound by a fabric or other constraint element,which is removed or otherwise released prior to engagement with thevalve leaflets. Alternatively, the hooks, barbs, or other appropriateelements may be formed of a self-expanding material, such that theintended profile/configuration may be taken on after delivery.

Tethers, tension elements, infusion ports, or other appendages, if fixedto the implantable devices, may be severed or otherwise separated fromthe implantable devices through the use of an end-cutting device, whichcan be individually passed over or near the appendage. Alternatively, anattenuated area may be constructed into the appendage such that anatural breakage site can create a severance by twisting, pulling orotherwise manipulating the appendage. Other means of separating tethers,tension elements, infusion ports, or other appendages, if fixed to theimplantable devices, as appropriate, may be employed, either through thecharacteristics of the ancillary elements or appendages, or throughintroduction of a separate component to create the separation, asappropriate.

The present invention allows attachment of the central orifice orneo-annulus to the heart or blood vessel wall by a continuous suspensionelement (previously disclosed, see U.S. Patent Application PublicationNo. 2010/0262232 and International Patent Application No.PCT/US2010/001077), by discontinuous suspension components, with orwithout a specific margin. Alternatively, the central orifice orneo-annulus may be supported only by the delivery system until fixationof the orifice ore neo-annulus to the native valve can be achieved.

In the current disclosure, the scaffold can be secured to the heart orvessel wall, such that a valve may be delivered through a limitedintrusion by utilizing a catheter to deliver and assemble the heartvalve components in-situ. This disclosure describes a scaffold which maybe attached to the heart or blood vessel wall in a limited way, or elsesimply stabilized while the valve is inserted, deployed, andsubsequently affixed to the native valve, rendering the initialattachment of the scaffold, or neo-annulus of lesser or only temporaryimportance to the ultimate fixation of the replacement valve.

Because the replacement valve must be deployed into approximately thesame location as the native valve, it is necessary to alter the positionof the native valve. In the current invention, a mechanism for pullingthe native valve leaflets toward the periphery of the neo-annulus andaway from the valve center is also provided

Because this fixation of the generally round scaffold, or neo-annulus tothe native valve would require that the two be more-or-less sealedcircumferentially, it is possible that native valve leaflets may requireplication or otherwise reconfiguration, such that peri-valvular leakagedoes not occur. A device and method for achieving this reconfigurationis disclosed herein.

Attachment of Scaffold to Heart Wall Via Fasteners Slid Along RespectiveTethers

The present invention provides devices and mechanisms for fixation of amargin of a scaffold or valve support device to the heart or vesselwall, as well as devices and mechanisms for incorporation of thesub-valvular apparatus, in the case of atrio-ventricular valves, to theimplanted scaffold or neo-annulus.

In the principal embodiment of the present invention, the scaffold has aseries of tethers or support elements attached to its outer edge ormargin at intervals around its circumference. In this iteration, thereare preferably primary and secondary tethers. The margin of the scaffoldor valve support is attached to the heart or vessel wall at the pointson the margin where the primary tethers are attached. Because threepoints determine a plane, in most cases there are three primary tethers(but could be more or fewer). Secondary tethers may be used to positionadditional fixation points of the scaffold margin after the scaffoldmargin is attached to the implantation site at the primary points. Insome cases it may not be necessary for the secondary tethers to have theability to manipulate the margin of the scaffold.

The scaffold, which is generally delivered through the lumen of acatheter, is advanced out the tip of said delivery catheter andmanipulated in into the desired position through the process ofadvancing or retracting the primary tethers. The delivery catheter isadvanced through the blood vessels or cardiac chamber of the patient andpositioned in the appropriate site for scaffold delivery and subsequentfixation. In general, the scaffold is crimped or otherwise packed in thecatheter lumen, then pushed or otherwise extruded from said catheter.The scaffold may expand automatically from the collapsed insertionconfiguration to the opened implantation configuration.

In a preferred embodiment, the tip of the delivery catheter is steerablein at least one direction, such that the position of the scaffold can bedirected to the proper location, not unlike a movie projector aims afilm image at a screen. The steering element may be a property of thedelivery catheter on by placing a movable element into the catheterlumen after the scaffold has been advanced. The scaffold can be movedtoward the appropriate location by advancing or otherwise manipulatingthe tethers. The orientation of the scaffold is controlled bydifferentially advancing the tethers, particularly the primary tethers.Steerability may not be needed in instances where a heart wall is thesite of introduction of the delivery system.

Once the appropriate locus of the scaffold margin has been reached, thetethers serve not only as holders to maintain position of the scaffoldposition, but also as support for passage and placement of marginfixation devices. In this embodiment, the sites and number of fixationpoints are determinable by the number and spacing of the primary andsecondary tethers around the scaffold margin.

Once fixation is deemed to be satisfactory, and fasteners have beenadvanced or otherwise placed, the tethers are detached from the scaffoldmargin, leaving the scaffold, attached at intervals around itscircumference, to the heart or blood vessel wall. By advancement of thefixation devices over the tethers, a means is provided wherebymanipulation of fixation elements and placement of those elements atspecific points around the circumference of the scaffold from a remotelocation and through a catheter is possible. Fixation of the outerscaffold margin to the heart, once achieved, provides support for theneo-annulus, because of its connection to the margin by an interveningmember such as a membrane.

In a principal iteration, fixation elements slide over the primary andsecondary tethers, advanced by sheaths slidably positioned around andover the tethers. The fixation elements, in one form, consist ofindividual screw-like devices, each of which is located on a respectiveone of the tethers. The devices in this case each comprise a doublehelix attached to a cap that may take the form or a circular disk. Thecap has a hole and is passed over the tether (the tether traversing thehole), such that the screw-like fixation device can be advanced over therespective tether to the margin of the scaffold and into the heart orvessel wall.

The double helix can be either twisted or simply pressed into the wall.Typically, pushing the associated sheath in the distal direction overthe respective tether and against the cap of the screw-like fastener orfixation device first causes the distal tips of the helix wires toinsert into the tissue and then induces turning of the helix about itslongitudinal axis. The helices may have one or more barbs or otherelements to inhibit their unintended dislocation. Such a barb or otherelement may be activated after acceptable deployment has been achieved.Once the fixation element is embedded in the heart or blood vessel wall,the tether can be detached (for instance, by a twisting action or asimple withdrawal), leaving the fixation element holding the scaffoldmargin to the wall. In this instance, the cap can straddle the marginwith one or both of the helical elements perforating the membranouselement.

Alternatively, the fixation elements or fasteners may take the form of adouble, pronged or pincer-like staple or other appropriate design,pre-formed or super-elastic element that, when applied to the marginover the tether, fixates the margin to the heart or vessel wall. Theremay be an element of the device in this instance to hold the marginelement with or without perforating the membranous element of thescaffold.

In any fastener or staple design, there may an element in the cap of thefastener or staple that prohibits the dislodgement of that fastener. Forexample, the cap of a helical fixation element may have a pin, whichwhen advanced, enters the heart or blood vessel wall and prohibitsunintentional untwisting and removal. Similarly, staples or prongedfasteners may have a spring-loaded barb or hook, which advances into theheart or blood vessel wall with no resistance but prohibits withdrawalof the staple.

The tethers may be disconnected from the scaffold after fixation eitherby unscrewing, twisting to fracture, or other means of separation fromthe margin of the scaffold. Alternatively, a tool can be introduced intothe target heart or blood vessel that is manipulated to induce theseparation.

With certain valves in the heart (specifically the atrio-ventricularvalves), the sub-valvular structures are important for chamber function.It has been recommended, therefore, when replacement is performed ratherthan repair, that these structures be incorporated into the annulus ofthe new valve. (See M. A. Borger, et al Ann Thoracic Surg 281:1153-1161.) The present invention provides a device and method forincorporation of these structures into the scaffolding, therebypreserving ventriculo-annular contribution to systolic function.

Accordingly, another feature of the present invention relates to adevice and means for attachment of the native valve, or sub-valvularstructures (in the case of the mitral or tricuspid valves) to either theneo-annulus or another part of the implanted scaffold. In the principalembodiment, these consist of one or more hooks, clips, barbs, or otherappropriate means of grasping the valve leaflet(s) or cordae tendineaeand attaching them either directly or with an intervening element tosome portion of the scaffold, such that, in the case of theatrio-ventricular (A/V) valves, systolic ventricular forces on a valveimplanted into the neo-annulus will be transmitted to the papillarymuscles and cords rather than to the fixation points of the scaffoldmargin alone, thus preserving systolic A/V valvular/papillary function.

In a preferred embodiment, the incorporation of the valve orsub-valvular elements is accomplished after the scaffold orvalve-support device has been fixed to the heart or blood vessel wall. Aseparate tool is then introduced into the chamber or blood vesselwhereby the valve leaflets are “snagged” by one or more hooks or barbs.In a most preferred embodiment, a device with multiple hooks is advancedthrough a catheter and across the valve orifice when it opened, as inforward flow, and retracted when the valve closes, piercing or otherwisecapturing the leaflets, such that they (the leaflets) can be pulled intothe scaffold as desired. In such an embodiment, the hooks or barbsseparate so that the individual leaflets are not tethered to each otherwhen the cycle requires the valve to open, thereby avoiding anobstruction.

The hooks or barbs, which actually capture or entrain the leaflets, maybe reversibly or temporarily attached to a delivery or deploymentdevice, which advances the hooks or barbs out of a catheter and throughthe valve orifice as noted above. In one iteration, the hooks attach orsnap into a deployment element, which is passed from a delivery catheterthrough the valve orifice, between the leaflets. The delivery ordeployment device then orients the hooks or barbs, and either activelyor passively releases them once the hooks or barbs engage the leaflets.Tethers (tensile elements) may be attached to the hooks or barbs for usein further manipulating the hooks or barbs, such as by twisting orapplying tension to increase or maintain purchase of the hooks or barbsinto the leaflets or subvalvular structure.

Because the coaptation surface of some valves is linear or planer, whilethe replacement or prosthetic valve to be placed is round, it may bedesirable to have the hooks or barbs dispersed or spread around theperimeter of the replacement valve. Therefore, there may be a feature ofthe deployment element that “fans out” or separates the hooks or barbsas they leave the delivery catheter. Such a device element could consistof a released spring, elastic material, pre-shaped memory substances,active opening, or other appropriate means of dispersing or separatingthe hooks or barbs over a length of valve leaflet before attachment ofthe valve-grasping elements to the scaffold or valve support system.

The present invention contemplates snagging the valve leaflets androlling them up into the new valve annulus or into the scaffold or valvesupport system. The natural valve leaflets are generally disabled bybeing marginalized, around the edge of the new valve or neo-annularelement of the scaffold or heart valve support system. This procedure isakin to gathering a curtain at the edge of a window and wrapping ittight to the new frame. In the case of the A/V valves, the cordaetendenae, which are still attached to the papillary muscles orventricular wall, transmit their forces to the margin of the new valveor the scaffold. The force generated by ventricular systole keeps theprosthetic valve and scaffold from being dislodged into the atrium.

Another issue is that the anterior leaflet of the mitral valve, ifmalpositioned, can obstruct the LV outflow tract causing subvalvularaortic stenosis. This is called “SAM”, or systolic anterior motion, andcan be the consequence of mitral repair done imperfectly. With a purein-valve replacement of the mitral, the anterior leaflet may bedisplaced into the sub-aortic position, which would potentially createSAM and could be deleterious to cardiac function.

The present invention contemplates a leaflet capture device with hooks,barbs, or other appropriate components that grasp and entrain the valveleaflet edges and curl the leaflets against the replacement valveannulus or scaffold margin, thereby retracting and disabling theleaflets around the margin of the replacement valve or into thescaffold. This procedure has the additional benefit of sealing the edgeor margin of the scaffold against leakage. The bunched up leaflets serveas a “gasket” against leakage of blood back into the atrium, therebymaking discontinuous attachment to the heart or blood vessel wall of thescaffold margin to the atrial wall feasible from a standpoint ofvalvular or peri-valvular regurgitation.

In the case of the aortic or pulmonary valves, the scaffold or heartvalve support system would be fixed either on the ventricular orarterial side of the valve with fixation thereto. In the case of theaortic valve, if placed in the aorta, the scaffold or valve supportsystem is perhaps best placed in a sub-coronary ostial position so asnot to obstruct coronary flow. In this application of the invention, thehooks, barbs or other appropriate components for grasping the valves aremodified to grasp or entrap the leaflets from the convex side of theleaflet, thereby ensnagging or otherwise achieving leaflet fixation onor through the ventricular surface or coaptation surface/margin of thevalve.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view of the mitral valve from the left atrium.

FIG. 2 is a view of a deployed implantable scaffold component inaccordance with the invention, showing an outer margin, a membranousportion, an orifice for valve placement, and a neo-annulus.

FIG. 3 is a view from the left atrium of the implantable scaffold fixedin position adjacent to a mitral valve.

FIG. 4 is a view of a delivery system crossing the inter-atrial septumfrom the right atrium to deploy the device over the mitral valve.

FIG. 5 is a view of a collapsed implantable scaffold in accordance withthe invention emerging from the tip of the delivery system.

FIG. 6 is a view of a completely extruded implantable scaffold inaccordance with the invention, having guide wires that are used tomanipulate the scaffold for placing it in position.

FIG. 7 is a view of an implantable scaffold component showing oneembodiment for fixing the outer margin to the adjacent tissue walls.

FIG. 8 is a view of the implantable scaffold component of FIG. 7 afterfixation, and after release from the catheter delivery system, so thatthe neo-annulus is now capable of receiving a circular valve prosthesisthrough the same or another delivery system, though the valve prosthesiscould also be surgically implanted.

FIG. 9 is a photograph that includes a diagram of an implantablescaffold in accordance with the invention showing diagrammatically howthe implantable margin is fixed at the mitral annulus, an abbreviatedmembranous portion separating the spaces, and a cylindrical implantedvalve with apposed leaflets in profile resides within the neo-annulus.

FIG. 10 is a photograph that shows loop tethers surrounding the cords,which in this iteration, are pulled though the neo-annulus so that withsubsequent fixation of the valve, papillary function may continue toimpact cardiac function.

FIG. 11 is a diagram showing a four-chamber view of the heart with themargin of an implantable scaffold in accordance with the invention fixedthrough the coronary sinus and the atrial septum.

FIG. 12 is a schematic view of the mitral valve and atrial septum fromthe dome of the atrium. The tricuspid valve is not illustrated. Theroute of the coronary sinus is shown under the left atrial wall androughly parallel to the posterior annulus.

FIG. 13 is a schematic view similar to FIG. 12, illustrating a separatedevice passed into the right atrium equipped with fixation elements,which can attach to a portion of the margin of the scaffolding forpartial anterior fixation.

FIG. 14 is a schematic view similar to FIGS. 12 and 13, showing ascaffold is a schematic view similar to FIG. 12 fixed through the atrialseptum as a result of the right atrial device used in FIG. 13.

FIG. 15 is a schematic view similar to FIG. 12, illustrating a separatedevice passed into the coronary sinus equipped with fixation elements,which can attach to the margin of the scaffolding for partial posteriorfixation.

FIG. 16 is a schematic view similar to FIG. 15, showing a scaffold inaccordance with the invention fixed through the atrial wall through thecoronary sinus as a result of the coronary sinus device used in FIG. 15.

FIG. 17 is a schematic view similar to FIGS. 14 and 16, showing thescaffold fixed through both the atrial septum and the coronary sinus asa result of the right atrial device used in FIG. 13 and the coronarysinus device shown in FIG. 15.

FIG. 18 is a schematic top plan view showing a collapsed valve scaffolddevice in accordance with the invention emerging from a distal end ofthe delivery catheter. In this iteration, a series of tethers or cordsattached either to the margin, through the membranous portion, or morecentrally, and are used to propel and position the scaffolding intoplace around the annulus.

FIG. 19 is a schematic view similar to FIG. 18, showing the expandedimplantable valve scaffold maneuvered into position by one or moreguiding cords, tethers, guide wires or filaments, which allowadvancement or retraction of any portion of the margin of theimplantable into apposition with the tissue at the desired location.

FIG. 20 is a schematic view similar to FIG. 19, showing the guidingcords, tethers, wires or filaments, advanced or else a fixation deviceat the end of each cord, tether, guide wire or filament is advanced atthe margin to perforate the tissue and accomplish fixation. The fixationportion may be a detachable portion of the guides, or a separate elementeither advanced by or over the guides.

FIG. 21 is a schematic front elevational view of the implantablescaffold of FIGS. 19 and 20, showing the cords as retracted into thecatheterso as to leave the deployed, fixed implantable valve scaffoldwith the neo-annulus located centrally over the native valve (notshown).

FIG. 22 is a diagram showing the mitral or tricuspid leaflet, with thecords and papillary muscle depicted in a long axis view.

FIG. 23 is a diagram similar to FIG. 22, showing a pre-formed orsteerable catheter passed around the cords or papillary muscle. In thisview, the catheter is coming from the atrium, but the catheter couldalternatively pass through the ventricular wall or ventricular outflowvalve.

FIG. 24 is a diagram similar to FIGS. 22 and 23, showing a second,sliding catheter passed over or adjacent to the shaft of the firstcatheter, or by some other route or guidance system, such that the opendistal ends of the two catheters appose, creating a continuous lumen.

FIG. 25 is a diagram similar to FIGS. 22-24, showing a continuous tetherpassed through the looping and sliding catheters, retrieved out theproximal ends of the catheters.

FIG. 26 is a diagram similar to FIGS. 22-25, showing that the second,sliding catheter has been removed revealing one part of the tethersurrounding the cords

FIG. 27 is a diagram similar to FIGS. 22-26, showing that the preformedor steerable catheter, which previously surrounded the sub-valvularapparatus, has been removed revealing the free tether surrounding thecords, available for incorporation into the scaffold or valve.

FIG. 28 is a diagram showing a four-chamber view of the heart with acylindrical sheath, framework, or other support added at a neo-annulusof an implantable scaffold in accordance with the invention to act as alanding zone for a subsequently placed valve

FIG. 29 is a diagram similar to FIG. 22 but showing an alternativeembodiment for capture of the sub-valvular apparatus where an element isdelivered to the underside of the valve leaflet (shown as a single barbon a single leaflet), to engage the valve on or near the attachment ofthe cordae, allowing an extension of the barb to attach to thescaffolding or neo-annulus allowing transmission of papillary systolicforces to the valve.

FIG. 30 is a schematic cross-sectional view of the left atrium and leftventricle of a heart, showing mitral valve leaflets in a nearly closedconfiguration.

FIG. 31 is a schematic view similar to FIG. 29, showing a deliverycatheter passed across the inter-atrial septum from the right atriuminto the left atrium.

FIG. 32 is a schematic view similar to FIG. 30, showing an early stageof an implantation procedure wherein expanding ventricular fixationhooks of a collapsed valve-seating scaffold in accordance with anotherembodiment of the invention extend out of a distal end of the deliverycatheter of FIG. 30.

FIG. 33 is a schematic view similar to FIG. 31, showing an intermediatestage of an implantation procedure wherein a partially expanded annularmember of the scaffold is disposed generally between the mitral valveleaflets and wherein the ventricular fixation hooks of FIG. 31 extendfrom the annular member behind the mitral valve leaflets.

FIG. 34 is a schematic view similar to FIG. 32, showing a laterintermediate stage of the implantation procedure wherein the annularmember of the scaffold is further expanded and the mitral valve leafletsare folded or curled into a compact configuration and wherein theventricular fixation hooks of FIGS. 31 and 32 are attached to the mitralvalve leaflets.

FIG. 35 is a schematic view similar to FIG. 34, showing in a still laterintermediate stage of the implantation procedure wherein the scaffold iscompletely ejected from the delivery catheter and wherein now deployedatrial fixation hooks are extend from the annular member into the atrialchamber and are connected to the mitral valve leaflets.

FIG. 36 is a schematic view similar to FIG. 35, showing terminal stageof the implantation procedure wherein a prosthetic valve is seated inthe orifice of the valve scaffold.

FIG. 37 is a diagram similar to FIG. 27, showing the two-strand tethersurrounding the cords, inserted between the scaffold and valve.

FIG. 38 is a diagram similar to FIG. 37, showing a fastener or lockingelement crimped to the two strands of the tether.

FIG. 39 is a side view of a grappling hook for capturing thesub-valvular apparatus in a method in accordance with the invention.

FIG. 40 is a front view of the grappling hook of FIG. 39.

FIG. 41 is a top plan view of the grappling hook of FIGS. 39 and 40.

FIG. 42 is a schematic view similar to FIG. 37, showing use of thegrappling hook of

FIGS. 39-41 in an implantation procedure as described below withreference to FIG. 29.

FIG. 43 is a diagram similar to FIG. 42, showing a fastener or lockingelement crimped to a tether or tension member of the grappling hook ofFIGS. 39-42.

FIG. 44 is a view from the left atrium towards the mitral valve, showingan implantable scaffold in accordance with the invention fixed inposition over a mitral valve and further showing two flexible tensionmembers or tethers extending between the scaffold and a prosthetic valveinserted into the scaffold.

FIG. 45 is a view similar to FIG. 44, showing a spacer extending betweenthe two tension members or tethers.

FIG. 46 is a schematic partial side elevational view of avalve-receiving scaffold in accordance with the invention and a means ofattaching the scaffold to a heart wall.

FIG. 47 is a view similar to FIG. 46, showing an alternative means ofattaching the scaffold to a heart wall.

FIG. 48 is a front elevational view of a scaffold or valve-supportimplant in accordance with the invention, showing the implant in apartially collapsed configuration.

FIG. 49 is a partial cross-sectional view of a heart wall and a partialside elevational view of an embodiment of a valve-support scaffold inaccordance with the invention, showing an alternative method ofattachment of the latter to the heart wall, pursuant to the invention.

FIG. 50 is a schematic longitudinal cross-sectional view of a deliverycatheter containing an implantable device in accordance with the presentinvention, in a collapsed, low profile configuration to facilitateminimally invasive access.

FIG. 51 is a schematic side elevational view of a tubular tethersurrounding a proximal portion of an elongate tension member or tensilecoupling element provided at a free or distal end with an entrainmentelement in the form of a grappling hook.

FIG. 52 is a schematic side elevational view of the delivery catheter ofFIG. 50 as advanced through a vascular system of a subject to a nativeheart valve.

FIG. 53 is a schematic side elevational view similar to FIG. 52, showinga multiplicity of hook-like entrainment or capture elements on tensilecoupling members as shown in FIG. 51, advanced inside the native valveof FIG. 52 into a heart chamber or blood vessel.

FIG. 54 is a schematic side elevational view similar to FIGS. 52 and 53,showing the delivery catheter retracted back across the native heartvalve with the hooks and tension members remaining in place.

FIG. 55 is a schematic perspective or side elevational view similar toFIGS. 52-54, showing partial extrusion or ejection of a neo-annulusscaffold or valve support member from the delivery catheter, while hooksand tension elements remain in place adjacent to the native valveleaflets.

FIG. 56 is a schematic perspective view similar to FIGS. 52-55, showingthe scaffold expanded in a heart chamber or blood vessel, ready formanipulation or positioning by a series of tethers like the tether ofFIG. 51.

FIG. 57 is a schematic perspective view similar to FIGS. 52-56 showinginitial purchase or entrainment of the native heart valve leaflets bythe hooks of the tensile coupling elements, which condition of initialentrainment still allows normal or near normal valve function.

FIG. 58 is a schematic perspective view similar to FIGS. 52-57, showinga prosthetic or bio-prosthetic replacement valve deployed into anorifice of the scaffold or valve support member.

FIG. 59 is a schematic perspective view similar to FIGS. 52-58, showinga neo-annulus/replacement valve complex advanced towards the orifice ofthe native valve by exertion of a retractive or proximally directedforce on the tensile coupling elements and a simultaneous exertion of apushing or distally directed force on the tubular tethers.

FIG. 60 is a schematic perspective view similar to FIG. 59, showingfurther advancement of the neo-annulus/replacement valve complex towardsthe orifice of the native valve.

FIG. 61 is a schematic perspective view similar to FIGS. 52-60, showinga seating of the neo-annulus/replacement valve complex into the orificeof the native valve and full retraction of the tension or couplingmembers.

FIG. 62 is a schematic perspective view similar to FIG. 61, showing theneo-annulus/replacement valve complex seated the orifice of the nativevalve after removal of the tethers and severing of the tensile couplingelements.

FIG. 63 is a schematic perspective or side elevational view, showing astep of an alternative valve implantation procedure, wherein aring-shaped neo-annulus scaffold or valve support member is providedwith a plurality of elongate flexible suspension elements that are fixedto the heart or blood vessel wall via respective removably attacheddeployment tethers that deliver staples or clips.

FIG. 64 is a schematic perspective view similar to FIG. 63, showing theneo-annulus scaffold supported by the deployed elongate suspensionelements of FIG. 63, and with the deployment tethers of FIG. 63 removed,ready for valve capture and replacement valve deployment, followed byadvancement of the complex into the native valve orifice.

FIG. 65 is a partial schematic perspective view similar to FIG. 63,showing a detail of an alternative, auto-fixation, method of attachmentof a suspension line to a heart or vessel wall.

FIG. 66 is a schematic plan view of a native mitral valve, showing valvecommissures.

FIG. 67 is a schematic plan view similar to FIG. 66, showing aring-shaped neo-annulus scaffold in place over the native mitral valve.Hooks for valve leaflet capture and the associated tensile couplingelements are visible through the orifice of the neo-annulus scaffoldwhile the positioning tethers of FIG. 51 extend between the deliverycatheter and the neo-annulus, the lumen of the catheter being shown incross-section.

FIG. 68 is a schematic plan view similar to FIGS. 66 and 67, depictingthe neo-annulus scaffold in position abutting the valve leaflets andwith a prosthetic or bio-prosthetic replacement valve deployed, furtherdepicting commissures leaving gaps in the seal around the neo-annulus,resulting in a perivalvular leak.

FIG. 69 is a partial schematic perspective view of the neo-annulusscaffold and replacement valve of FIG. 68 in position abutting thenative-valve leaflets, illustrating a gap at a commissure, and alsoschematically illustrating locks on the tensile coupling elementsholding them in place relative to the neo-annulus.

FIG. 70 is a series of three side elevational views of a tissueapproximation clip or anchor in three configurations relative to apposedvalve leaflets, initially inserted through a commissure gap, thenretracted causing apposition of the leaflets and a filling of the gap,and finally with prongs bent for permanent placement.

FIG. 71 is a partial schematic perspective view similar to FIG. 69,showing the anchor-shaped clip of FIG. 70 deployed for leaflet-edgeapproximation.

FIGS. 72A and 72B are a pair of partial schematic cross-sectional viewsof an annulus or ring-shaped valve support member, a tether and atensile coupling element, FIG. 72A showing a collapsed bladder-likecomponent, along with an inflation-port, FIG. 72B showing thebladder-like component after inflation.

FIG. 73 is a schematic partial side elevational view of a neo-annulusscaffold in apposition with a captured valve leaflet with the inflatablecomponent of FIGS. 72A and 72B in an expanded configuration sealing aline of contact and with infusion tube and port still attached.

FIG. 74 is a partial schematic perspective view similar to FIG. 71,showing a bladder-like sealing component disposed around a periphery ofthe neo-annulus scaffold in a deflated insertion configuration.

FIG. 75 is a partial schematic perspective view similar to FIG. 74,showing the bladder-like sealing component in an expanded sealingconfiguration, covering or closing a gap between valve leaflets.

FIG. 76 is a schematic side elevational view of ratchet-type lockingcomponents provided on the neo-annulus scaffold and the distal end of atensile coupling element to allow only one-way excursion of the tensilecoupling element and its appended valve-capture or entrainment element(not shown), the tether being pushed in the distal direction and thetensile coupling element being pulled in the proximal direction to clampthe neo-annulus scaffold and attached replacement valve to the valveleaflets.

FIGS. 77A and 77B are a schematic perspective view and a schematiclongitudinal cross-sectional view, respectively, showing anotherembodiment of a ratchet mechanism.

FIG. 78 is a schematic perspective view of a neo-annulus scaffold withcollapsed perimetral closure bladder, tensile coupling elements withdistal hooks entrained to the ends or edges of native valve leaflets,and tubular tethers extending from the distal end of a delivery catheterand holding the scaffold in position for installation.

FIG. 79 is a schematic perspective view similar to FIG. 78, showing areplacement valve mounted to the neo-annulus scaffold.

FIG. 80 is a schematic plan view of the neo-annulus scaffold of FIGS. 78and 79 in place above the native mitral valve with native valve captureand the “sewing ring” or closure bladder inflated, but with thereplacement valve omitted.

FIG. 81 is a schematic side elevational view of a helical fastener witha truncated sleeve, which is slidably disposed over ascaffold-positioning tether, in accordance with the present invention.

FIG. 82 is a schematic perspective or isometric view of a helicalfastener similar to that of FIG. 81 sliding over a tether. FIG. 82 alsodepicts a portion of a pusher sleeve or tube.

FIG. 83 is a schematic partial cross-sectional view of the helicalfastener of FIG. 81 juxtaposed to a heart wall and a margin of avalve-support scaffold.

FIG. 84 is a schematic partial cross-sectional view similar to FIG. 83,showing the helical fastener advanced into the heart wall, with thefastener straddling the margin of the scaffold.

FIG. 85 is a schematic partial cross-sectional view similar to FIG. 84,showing the fastener partially embedded in the heart wall with thepusher sleeve or tube withdrawn, but the tether still attached to thescaffold margin.

FIG. 86 is a schematic partial cross-sectional view similar to FIG. 84,showing the fastener partially embedded in the heart wall and holdingthe scaffold in place, but with the tether removed, this viewrepresenting the ultimate state of scaffold fixation.

FIG. 87 a schematic perspective or isometric view of a valve-supportscaffold in an expanded configuration and a plurality of positioningtethers.

FIG. 88 is a view similar to FIG. 87, showing a pusher sleeve or tubeadvanced over a tether and in contact with a helical fastener at themargin of the valve-support scaffold, for deployment of the fastenerinto a heart or blood vessel wall.

FIG. 89 is a schematic side elevational view of an alternative,two-pronged staple for fastening a margin of a valve-support scaffold toa heart or blood vessel wall.

FIG. 90 is a schematic cross-sectional view of the staple of FIG. 89with the prongs partially inserted into a heart or blood vessel wallover a margin or rim element of a valve-support scaffold or frame.

FIG. 91 is a schematic cross-sectional view similar to FIG. 90, showingthe prons or legs of the staple in an angled-apart or expandedconfiguration to create fixation.

FIG. 92 is a schematic cross-sectional view of a second alternativestaple configuration wherein the tips turn in to create fixation.

FIG. 93 is a schematic cross-sectional view similar to FIG. 92, shows aprong of the staple provided with a removal-prevention barb.

FIG. 94 is a schematic perspective or isometric view of a valveretrieval system, for capturing leaflets of a natural atrial valve andindirectly capturing the cords (not shown), showing the natural valve ina closed state.

FIG. 95 is a schematic perspective or isometric view similar to FIG. 94,showing the valve in an opened state.

FIG. 96 is a schematic perspective or isometric view similar to FIGS. 94and 95, showing the valve retrieval system advanced through the openvalve.

FIG. 97 is a schematic perspective or isometric view similar to FIG. 96,showing the valve closed around the valve retrieval system.

FIG. 98 is a schematic perspective or isometric view similar to FIG. 97,showing the retrieval system engaging the valve, with the deliverysystem retracted.

FIG. 99 is a schematic perspective or isometric view similar to FIG. 98,showing a pair of leaflet-capture tethers or the retrieval systemshifted apart to engage and curl or otherwise engage and/or retract theleaflets

FIG. 100 is a schematic perspective or isometric view similar to FIG.99, showing the retrieval system delivery apparatus removed.

FIG. 101 is a view similar to FIG. 100, showing the tethers of theretrieval system drawn through a valve-receiving neo-annulus or apertureof a valve-support scaffold as a prosthetic valve is deployed into theneo-annulus of the scaffold.

FIG. 102 is a view similar to FIG. 101, showing the tethers of the valveretrieval system completely engaged with the valve leaflets and fixingthe leaflets to the valve-support scaffold as well as to the implantedprosthetic valve.

FIG. 103 is a view similar to FIG. 101, showing the native valveleaflets fully retracted and attached to the scaffold and the prostheticheart valve and with locking apparatuses connected on the tethers of theheart valve retrieval system to reinforce fixation of those tethers tothe scaffold and the deployed prosthetic valve.

FIG. 104 is a schematic perspective or isometric view of the helicalfixation device or fastener of FIG. 81, showing a pin disposed in a capof the helical fixation device, which, when advanced into the heart orblood vessel wall, prohibits untwisting of the helical fastener.

FIG. 105 is a view similar to FIG. 104, showing the pin in a deployed oradvanced position.

FIG. 106 is a schematic perspective view of an expanded valve-supportscaffold extended via positioning tethers out of a delivery catheter,showing the catheter in a pair of configurations illustratingsteerability of the catheter tip.

FIG. 107 is a schematic perspective or isometric view of a portion of aleaflet entrainment device in accordance with the present invention.

FIG. 108 is a schematic perspective or isometric view of a portion of amodified leaflet entrainment device in accordance with the presentinvention.

FIG. 109 is a schematic perspective or isometric view of a valveretrieval system inserted in a retrograde direction through an openedaortic valve.

FIG. 110 is a schematic perspective or isometric view similar to FIG.109, showing the aortic valve closed around the valve retrieval system.

FIG. 111 is a schematic perspective or isometric view similar to FIGS.109 and 110, showing the retrieval system engaging the valve.

FIG. 112 is a schematic perspective or isometric view similar to FIGS.109-111, showing a pair of leaflet-capture tethers or the retrievalsystem shifted apart and engaging and curling the leaflets.

FIG. 113 is a schematic perspective or isometric view similar to FIGS.109-112, showing the retrieval system delivery apparatus removed thetethers of the retrieval system drawn through a valve-receivingneo-annulus or aperture of a valve-support scaffold, and a prostheticvalve deployed into the neo-annulus of the scaffold.

DEFINITIONS

The word “tether” is used herein to denote an elongate member thatextends from outside a patient to an implantable device inside thepatient, especially but not necessarily within the vascular system. Atether is used to remotely manipulate and position the implantabledevice within the patient and may also be used to implement attachmentof the implantable device to organic tissues of the patient. It iscontemplated that a tether is normally detachable from the implantabledevice once implantation has been secured. A tether may be a wire madeof a metallic or metal alloy material and is capable of transmittingcompressive, tensile and torsional forces as required.

The terms “scaffold” and “neo-annulus” are used interchangeably hereinto denote an implantable device or structure that serves as a frameworkfor receiving a prosthetic valve and anchoring the valve to the patientat the site of a malfunctioning native valve. A scaffold or neo-annulusis preferably delivered to the operative site via a catheter.Consequently, the scaffold or neo-annulus must be flexible orcollapsible for insertion into the patient. Once the scaffold orneo-annulus is ejected from the catheter into the patient, the scaffoldor neo-annulus expans to a predetermined use configuration suitable forreceiving, seating and attaching to a prosthetic or bio-prostheticvalve. A scaffold or neo-annulus as decribed herein defines an orifice,preferably circular, for receiving a prosthetic or bio-prosthetic valve.

The term “prosthetic” as applied to a valve herein includesbio-prosthetic valves.

The term “force-transmitting and fluid-sealing contact” as used hereinwith reference to the implantation of a scaffold or neo-annulus injuxtaposition with or apposition to native valve leaflets means in partthat the scaffold or neo-annulus is attached at least indirectly to thenative valve leaflets so as to enable the transmission of operativenatural valve forces at least in part over the native valve to thescaffold or neo-annulus and the prosthetic valve attached thereto. Theterm “force-transmitting and fluid-sealing contact” also means that theimplanted scaffold or neo-annulus is effectively sealed relative to thenatural valve so that blood flow occurs essentially solely through theprosthetic valve upon completion of the implantation procedure. Sealingmay occur wholly or in part because of direct contact between thescaffold or neo-annulus and the native valve leaflets or between thescaffold or neo-annulus and the cardio-vascular wall about the nativevalve. A seal may be effectuated wholly or in part because of the use ofan ancillary sealing element or elements such as staples, clips orsutures or one or more inflatable bladders that close off potentialfluid flow channels about the scaffold or neo-annulus.

The term “cardio-vascular wall” is used herein to denote the innersurface of a heart chamber or a blood vessel into which a prostheticvalve and its associated scaffold or neo-annulus is implanted.

The terms “tensile coupling element” and “tension member” and variationsthereof are used herein to denote an elongate member such as a wirewhich may be pushed or pulled and thus supports both compressive andtensile forces, as well as torsional forces and which in part remains ina patient connecting a scaffold or neo-annulus to a patient undertension.

The terms “distal” and “distally directed” are used herein to denote adirection extending from an operator such as a surgeon, who is outside apatient, towards the patient and more particularly towards a valvularstructure inside a patient. Concomitantly, the terms “proximal” and“proximally directed” denote a direction extending towards an operatorsuch as a surgeon from a patient and more particularly from a valvularstructure inside a patient.

DETAILED DESCRIPTION

The present invention provides devices and associated methodology forattaching a valve-supporting scaffold or frame member to a subject,particularly to natural valve leaflets of a native heart or vessel valveof the subject. Such a valve-supporting scaffold and methods relatedthereto are disclosed in U.S. Patent Application Publication No.2010/0262232, the disclosure of which is hereby incorporated byreference.

As depicted in FIG. 1, a mitral valve 12 includes a pair of leaflets orvalve flaps 14 and 16 that contact one another along a generallyD-shaped set of points 17 in a closed state of the valve. On the atrialside of the valve 12, leaflets are continuous with an internal wall 18of the atrium.

As depicted in FIG. 2, an implantable valve scaffold or mountingcomponent 20 includes an outer margin or rim element 22, a membranousportion 24, and a generally annular inner margin or rim element 26defining an orifice 28. Orifice 28 serves as a neo-annulus for receivingor seating a prosthetic or bio-prosthetic valve 42 (FIG. 9). It iscontemplated that the valve is a modular or staple article. However, thevalve may be custom designed.

It is to be understood that the inner margin or rim element 26 generallyhas a circular or cylindrical shape, so as to enable the seating ofcommercially available prosthetic or bio-prosthetic valves, which arecircular or cylindrical. The term “annular member” is used herein todenote a continuous or endless configuration that defines an opening,orifice, or aperture. While the opening, orifice, or aperture istypically round or circular, the shape is not necessarily such. An“annular member” as that term is used herein particularly with referenceto the element that defines the valve-receiving orifice or neo-annulus,may be oval or even polygonal.

Scaffold or mounting component 20 is implantable, for example, into theleft atrium of a patient's heart, during a procedure to rectify andimprove improper valve functioning. FIG. 3 shows scaffold 20 fixed inposition over mitral valve 12.

Scaffold or support device 20 is comprises a generally rounded orsomewhat oval body member (not separately designated), shown in FIGS. 2and 3, which symmetric or asymmetric in two dimensions, but generallyflat in the third dimension. Outer margin or rim element 22 is apliable, conforming margin, which is generally continuous around theperimeter of the scaffold 20 and is able to take on a variety of shapesso that it can conform to the topography of the heart wall to which itis being attached. The scaffold device can be permanently fixed to thetissue.

Outer margin or rim element 22 is disposed generally in a plane andcircumferentially surrounds pliant membrane 24, such that the margin isattached to the heart tissue and together with the membrane creates abarrier to blood flow. The barrier would be obstructive, were it not fororifice 28 in roughly the center of membrane 24, which is generallyround and flexible but generally inelastic. Orifice 28 provides aneo-annulus into which a prosthetic or other valve can be inserted andattached to the scaffold or support device 20. Scaffold 20 provides ameans of placing a valve into a site adjacent to a native valve annulus,in a way unencumbered by the limitations of the native valve annulus.

FIG. 4 illustrates a delivery system and a means by which the outermargin or rim element 22 of scaffold or support device 20 can be fixedto the tissue of a heart or vessel wall, generally over or behind aheart valve such as mitral valve 12 of FIGS. 1 and 2. The deliverysystem includes a delivery catheter 30 and a plurality of guide wires,filaments, or cords 32 that are removably connected at their distal endsto outer margin or rim element 22. Guide wires, filaments, or cords 32may be manipulated to shape outer margin or rim element 22 in-situ tomatch the contours of the surface to which the valve will be attached.Guide wires, filaments, or cords 32 are attached to various portions ofthe outer margin or rim element 22 at spaced points therealong. Guidewires, filaments, or cords 32 are used as manipulators to adjust theshape and position of the scaffold 20, and to hold it in position whilethe outer margin or rim element 22 is fixed to the adjacent tissuesurface.

As schematically represented in FIG. 4, delivery catheter 30 may beinserted into the left atrium 36 by crossing the inter-atrial septum 38from the right atrium 40 to deploy the valve scaffold or support device20 over the mitral valve 12 (FIG. 3).

FIG. 5 depicts scaffold 20 in an intermediate stage of ejection fromdelivery catheter 30. At the onset of a percutaneous implantationprocedure, when catheter is being manipulated through the vascularsystem, preferably the venous system, to the heart, scaffold 20 isstored in a collapsed configuration inside a distal end portion of thecatheter. Alternatively, the collapsed scaffold may be inserted into aproximal end of the catheter and pushed to the distal end after thearrival of the distal end at the surgical site.

FIG. 5 shows a partially expanded scaffold 20 emerging from the distalend of catheter 30 together with distal ends of a pair of guide wires,filaments, or cords 32. FIG. 6 similarly shows a completely ejected andexpanded scaffold 20 outside the distal end of catheter 30 with severalguide wires, filaments, or cords 32 extending from the lumen (notdesignated) of catheter 30 to outer margin or rim element 22.

As depicted in FIGS. 7 and 8, outer margin or rim element 22 may bepre-assembled with fixation elements 34, which engage heart tissue afterthe scaffold 20 is in position. Fixation elements 34 are spacedsufficiently close to one another to attach outer margin 22circumferentially to the tissue so as to create a continuous or nearcontinuous contact between the tissue and the scaffold 20. Fixationelements 34 may take any form suitable for achieving this result.Acceptable candidates include hooks, barbs, anchors, and aliquots ofadhesive. The adhesive may be initially in an inert form and activatedby the application of waveform energy, electromagnetic or ultrasonic, orpossible heat energy. A separate instrument may be inserted into theheart chamber or guided to the surgical site for activating theadhesive.

Once implantation of scaffold or support device 20 has been completed,orifice 28 is ready to receive a circular or cylindrical valveprosthesis 42 (FIG. 9) through the same or another delivery system,though the valve prosthesis could alternatively be surgically implanted.

Annular inner margin or rim element 26 may be either elastic orinelastic with respect to its circumference and may be rounded orirregularly shaped and asymmetric, as appropriate to the valvemorphology. In general, the combination of the implantable scaffold orsupport device 20 and the subsequently placed valve 42 (FIG. 9) willcreate complete separation between the chamber of fixation (e.g., 36)proximal and distal to the membrane margins, except for flow through thevalve.

For purposes of facilitating a surface substantial enough to allowfixation of a valve 42, orifice 28 acting as the neo-annulus may have acylindrical configuration, creating a surface rather than a rim. Thecylindrical surface of the annulus extends perpendicularly to the planeof the membrane portion 24 of the scaffold device 20 and the plane ofthe native mitral annulus and in alignment with or parallel to the bloodflow. The cylinder may be made of metal mesh, inelastic cloth, materialelastic in only one plane (the plane of the blood-flow), a coil, orother appropriate material.

The cylindrical surface may be an integral part of the implantedscaffold 20, or may be attached by a separate step at some time-pointafter the scaffold has been deployed. Fixation to the inner margin orannular member 26 may be by compression, hooks, barb, or otherappropriate means.

Valve scaffold or support device 20 may be provided with a means oftethering the sub-valvular apparatus into orifice 28 in order to takeadvantage of any potential contribution of the sub-valvular apparatus tocardiac function.

FIG. 9 depicts valve scaffold or support device 20 with outerconformable margin 22 fixed at the mitral annulus, an abbreviatedmembranous portion 24 separating the spaces, and cylindrical implantedvalve 42 with apposed leaflets in profile resides within theneo-annulus.

FIG. 10 is a photograph that shows loop tethers 44 surrounding the cordsor chordae tendineae 46 which in this iteration, are pulled though theneo-annulus orifice 28 so that with subsequent insertion and fixation ofthe valve 42, papillary function may continue to impact cardiacfunction.

Outer conformable margin 22 may be made of a pliant material, likelytubular in nature, in which fixation elements or fasteners 34 in theform of hooks, barbs, expandable anchors, or other appropriateattachment elements may be held. When the outer conformable margin orrim element 22 is positioned, fixation elements 34 are extended orotherwise deployed into the internal tissues of the atrial wall 18 tocause fixation. Parts of the outer conformable margin 22 may be attachedeither separately or all at one time. Outer margin 22 may be coveredwith a porous material such as polyester, or similar biocompatiblecovering to facilitate tissue in-growth.

Alternatively the fixation elements or fasteners 34 may comprise hooks,barbs, screws, anchors, staples, magnets, glue, stents, or otherfixation components that are delivered and deployed in part or totallyseparately from the implantable valve scaffold itself. Thus, valvescaffold 20 may be initially free of fixation elements or fasteners 34,with the fixation elements being attached in situ to the scaffold andthe host tissue surface.

Commercially available valves, as well as those in development forcatheter delivery and commercial availability in the future, aregenerally round, and, in the case of those designed for catheterdelivery, are used either trans-arterially or trans-apically in theaortic position, but have not been used for the mitral valve replacementbecause of the asymmetry of the annulus and native valve. These devicescannot fit within the asymmetrical contours of a heart chamber. However,using scaffold 20, this asymmetrical chamber opening is converted to around opening, thereby enabling existing round valve designs to beadapted for use in the mitral valve area.

Also, since the left atrium can be accessed through the venous systemacross the foramen ovale, it will accommodate a larger catheter than cangenerally be passed through the arterial side, and can address both thetricuspid and the mitral, neither of which now has a strategy forcatheter-based replacement.

In general, a significantly larger valve may be required in the mitralposition than in the aortic, and the valve 42 may be positioned into theorifice 28 of the neo-annulus by way of catheter 30, and expanded intothe orifice. Orifice 28 may be a hole that receives and seats valve 42.Alternatively, orifice 28 may have valve connectors pre-assembled withscaffold 20 prior to placement to facilitate mounting. Alternatively, astandard prosthetic or bio-prosthetic valve may be sewn into place in anopen procedure

The primary use of scaffold 20 is in the mitral area. However, scaffold20 may be adapted for use with the tricuspid, with slight modificationto allow for the coronary sinus orifice. Of course, scaffold 20 can beadapted for providing a neo-annulus in any location where such aneo-annulus would have therapeutic value. As the membranous portion 24can vary in size depending on the discrepancy in size between thedesired valve and the dimensions of the surrounding tissue to which thescaffold will be fixed, and the outer margin 22 is conformable tovirtually any irregular contour opening, it is clear that scaffold 20 isadaptable for location in many areas of the body, and is not limited tothe particular embodiments shown and described herein, as would beunderstood by one skilled in the art.

FIG. 11 diagrammatically depicts a heart 1 having a right atrium 102, aright ventricle 104, a left atrium 106, and a left ventricle 108, withvalve scaffold or support platform 20 implanted therein. Outer margin orperimeter element 22 is fixed via fasteners 118 and 120 through thecoronary sinus 114 and the atrial septum 116.

FIG. 12 schematically illustrates a mitral valve 126 and atrial septum128 from the dome of the left atrium 106 (FIG. 11) with scaffold orvalve support device 20 in position in the atrium adjacent the mitralvalve. The tricuspid valve is not illustrated. The route of the coronarysinus 130 is shown under the left atrial wall and roughly parallel tothe posterior annulus.

As shown in FIG. 13, a separate device 132 may be passed into the rightatrium 106 equipped with fixation elements 134, which can attach to aportion of the outer margin or rim element 22 of scaffold or valveplatform 20 for partial anterior fixation. FIG. 14 shows scaffold orvalve platform 20 fixed through the atrial septum 128 as a result of theright atrial device 132 used as depicted in FIG. 13.

As illustrated in FIG. 15, another surgical device 136 equipped withfixation elements 138 is passed into the coronary sinus 130. Fixationelements 138 attach to the outer margin or rim element 22 of scaffold orvalve support platform 20 for partial posterior fixation. FIG. 16 showsscaffold or valve support platform fixed through the atrial wall via thecoronary sinus 130 as a result of the coronary sinus device 136 used asdepicted in FIG. 15.

FIG. 17, a schematic view similar to those of FIGS. 14 and 16, showsscaffold or valve support platform 20 secured in position next to themitral valve 126 (A) by fixation elements or fasteners 134 extendingthrough the atrial septum 128 as a result of the use of the right atrialdevice 132 pursuant to FIG. 13 and (B) by fixation elements or fasteners138 extending from the coronary sinus 130 as a result of the use of thecoronary sinus device pursuant to FIG. 15.

FIG. 18 shows a collapsed configuration 140 of valve scaffold or supportdevice 20 emerging from a distal end of delivery catheter 30. In thisiteration, a series of tethers, cords, wires or filaments 142 areattached either to outer margin 22, through the membranous portion 24,or more centrally, and are used to propel and position the scaffold orvalve support device 20 into place around the annulus. Scaffold 20expands automatically by virtue of the internal stresses of the shapememory material such as titanium and nitinol of which the scaffold isfabricated. FIG. 19 depicts the expanded implantable valve scaffold 20maneuvered into position by one or more guiding cords, tethers, wires orfilaments 142, which allow advancement or retraction of any portion ofthe outer margin 22 of the implantable scaffold 20 into apposition withthe tissue at the desired location.

FIG. 20 diagrammatically shows the guiding cords, tethers, wires orfilaments 142 and a fixation element or fastener 34 at the end of eachcord, tether, guide wire or filament advanced at the margin 22 toperforate the tissue and accomplish fixation. Fixation elements orfasteners 34 may be detachable portions of cords, tethers, guide wiresor filaments 142, or separate elements advanced either by or over theguides 142. In FIG. 21 cords, tethers, guide wires or filaments 142 havebeen retracted into the catheter 30 so as to leave the deployed, fixedimplantable valve scaffold 20 with the valve-receiving orifice orneo-annulus 28 located centrally over the native valve (not shown).

FIG. 22 is a diagram showing a mitral or tricuspid leaflet 144, with thecords or chordae tendineae 146 and papillary muscle 148 depicted in along axis view.

As shown in FIG. 23, a pre-formed or steerable catheter 150 is passedaround the cords 146 and/or papillary muscle 148. In this view, catheter150 extends from the atrium 102 or 106 (FIG. 11), but the catheter couldalternatively pass through the ventricular wall or ventricular outflowvalve. As shown in FIG. 24, a second, sliding catheter 152 is passedover or adjacent to the shaft of the first catheter 150, or by someother route or guidance system, such that open distal ends 154 and 156of the two catheters appose, creating a continuous lumen.

Pursuant to FIG. 25 a continuous tether 158 is passed through loopingcatheter 150 and sliding catheter 152, via their apposed distal ends 154and 156, and extends out the proximal ends (not shown) of the catheters.In FIG. 26 sliding catheter 152 has been removed, revealing one part oftether 158 surrounding the cords 146. In FIG. 27 preformed or steerablecatheter 150, which previously surrounded the sub-valvular apparatus146, 148, has been removed, revealing tether 158 free and surroundingthe cords 146, available for incorporation into scaffold 20 or valve 42(FIG. 9). Pursuant to one option, tether 158 extends through orifice orneo-annulus opening 28 prior to the seating of the prosthetic orbio-prosthetic valve 42. Upon the seating of valve 42, tether 158 ispinched or clamped between inner margin or rim element 26 (see, e.g.,FIG. 2) and the seated valve.

The tethering of scaffold 20 and valve 42 to the subvalvular apparatus,i.e., cords 146 and/or papillary muscle 148, serves in part to anchorthe implanted devices 20 and 42 in position in opposition to thepressure exerted during ventricular systole. In addition, the anchoringpreserves the natural distribution of stresses throughout the heart andaccordingly reduces the likelihood of cardiac failure owing to animbalance in the forces affecting the heart muscles.

FIG. 28 is a diagram similar to FIG. 11 and utilizes the same referencedesignations for corresponding structures. As depicted in FIG. 28, acylindrical sheath, framework, or other support 160 is inserted into aneo-annulus orifice 28 of scaffold 20 to act as a landing zone for asubsequently placed prosthetic or bio-prosthetic valve (not shown).Tether 158 may be clamped between orifice margin or rim element 26 andcylindrical sheath, framework, or support 160. Sheath, framework, orsupport 160 provides increased surface area for attachment of anoff-the-shelf valve and may be provided with fasteners (not shown) tosecurely link to margin or rim element 26.

FIG. 29 shows an alternative embodiment for capture of the sub-valvularapparatus, including chordae tendineae 146 and papillary muscle 148,where a fastening element 162 is delivered to the underside 164 of valveleaflet 144 (shown as a single barb on a single leaflet), to engage themitral valve on or near the attachment of the cordae. Fastening element164 may take the form of a hook or barb 166 at the end of a tether 168.The hook or barb 166 is inserted into the tissue of the leaflet 144 andsecured thereto along underside 164 or to cordal junctions. Tether 168is left in place for incorporation into scaffold 20 or anchoring to thescaffold and the prosthetic valve, allowing transmission of papillarysystolic forces to the valve.

FIGS. 30 through 36 represent successive stages of a procedure forimplanting an alternative valve scaffold 300 in accordance withprinciples delineated herein. FIG. 30 depicts a left atrium 302 and leftventricle 304 of a heart 306, showing leaflets 308 and 310 of a mitralvalve 312 in a partially closed configuration representing amalfunctioning of the mitral valve. In a procedure deploying aprosthetic valve 314 (FIG. 36) to effectively replace the mitral valve312, a delivery catheter 316 is passed across the inter-atrial septum318 from the right atrium 320 into the left atrium 302, as shown in FIG.31.

A distal end portion of catheter 316 carries valve scaffold or mountingplatform 300 in a collapsed configuration (not shown). As describedhereinafter with reference to FIGS. 32-34, the scaffold or platform 300is ejected and expanded in stages to displace leaflets 308 and 310outwardly, to fold or curl the leaflets into a more compactconfiguration and to attach the scaffold or frame to the leaflets.Scaffold 300 is made of at least one shape memory material so that theexpansion and reconfiguration of the scaffold occurs automatically inresponse to the ejection of the scaffold from a distal tip 322 ofcatheter 316.

After a maneuvering of catheter 315 so that distal tip 322 thereof isjuxtaposed to mitral valve 312, as depicted in FIG. 32, the collapsedscaffold or valve-mounting platform 300 is pushed in the distaldirection relative to catheter 316 so that a plurality of ventricularfixation hooks 324 of the scaffold emerge from the distal tip of thecatheter and insert between the valve leaflets 308 and 310. Uponcontinued ejection of the collapsed scaffold 300 from catheter tip 322,an annular member 326 of the scaffold emerges into the gap betweenleaflets 308 and 310, as shown in FIG. 33. The ejected annular member326 automatically expands thereby folding leaflets 308 and 310 outwardlyinto curled configurations 328 and 330, as illustrated in FIG. 34.During or immediately prior to this expansion of annular member 326,ventricular fixation hooks 324 pivot towards the curling or foldingleaflets 308 and 310 and insert their distal tips between the chordaetendineae into the mitral valve tissues, thus attaching annular member326 to the mitral valve leaflets 308 and 310 on the ventricular sidethereof. FIG. 37 further illustrates an emergence, from catheter tip322, of a plurality of atrial fixation hooks 332 that are connected toannular member 326. The distended atrial fixation hooks, 332, to theextent that they are still entrained by friction forces to the deliverycatheter 316, may be used to fine tune the positioning of the scaffold300 by maneuvering catheter 316 to exert displacement forces on thescaffold via the extended and deformed atrial fixation hooks.

FIG. 35 shows a late stage of an the implantation procedure whereinscaffold 300 is completely ejected from delivery catheter 316 andwherein atrial fixation hooks 332 have been completely ejected fromcatheter 317 so that the hooks can assume a predetermined clamping orattachment orientation with distal tips of the hooks inserted into theatrial or mitral-valve tissues on the atrial side of the folded orcurled configurations 328 and 330 of the mitral valve leaflets 308 and310.

Annular member 326 of scaffold 300 defines a neo-annulus orifice 334 forreceiving or seating prosthetic or bio-prosthetic valve 314 (FIG. 36).Ventricular fixation hooks 324 and atrial fixation hooks 332 arefasteners connected at least indirectly to the annular member forattaching the same all around an outer margin thereof to an tissuesurface in the left atrium 302 and to a tissue surface in the leftventricle 304. The tissue surfaces may belong to the atrial leaflets orto the heart chamber walls.

Annular member 326 has a transverse dimension or thickness extendingperpendicularly to a major plane 336 (FIG. 35) of the annular member.Ventricular hooks or fasteners 324 extend from the annular member 326outwardly to one side of plane 336, towards the ventricle 304, whileatrial fixation hooks or fasteners 332 extend from the annular memberoutwardly to an opposite side of plane 336, towards the left atrium 302.Hooks or fasteners 324 and 332 define a space therebetween for receivingand constraining curled configurations 328 and 330 of leaflets 308 and310.

Annular member 326 and hooks or fasteners 324 and 332 are sized andconfigured to so constrain the curled configurations 328 and 330 ofmitral valve leaflets 308 and 310 that a satisfactory liquid tight sealis created between the curled or folded leaflets and the scaffold 300.Hooks or fasteners 324 and 332 are each made of a shape memory materialsuch as Nitinol, while annular member 326 is made of the same or adifferent shape memory material such as braided titanium.

When the implantable scaffold 3 s disposed in a collapsed deliveryconfiguration inside the distal end portion of delivery catheter 316,the annular member 326 assumes an elongate squashed shape such as thatassumed by a collapsed rubber band. The shape memory material of annularmember 326 is flexible but not elastic. Annular member 326 issubstantially rigid in the finally expanded configuration whereinneo-annulus orifice 334 is sized to seat prosthetic or bio-prostheticvalve 314 in a liquid tight fit.

FIG. 36 depicts a terminal stage of the implantation procedure whereinleaflets 308 and 310 and mitral valve cords (not shown) are fixed toannular member 326 and wherein prosthetic or bio-prosthetic valve 314 isseated in orifice 334 of the valve scaffold 300. Annular member 326 maybe provided with an annular lip or ridge (not shown) which is receivedin a groove (not shown) on a external wall 338 of valve 314, to enhanceof implement formation of a liquid-tight seal.

Hooks or fasteners 324 and 332 are circumferentially spaced about theannular member 326 with an inter-hook spacing of 1-3 mm. Hooks orfasteners 324 and 332 may take any form suitable for attachment toventricular, mitral valve and atrial tissues. The fasteners 324 and 332may be barbs, anchors, claws, or clips instead of or in addition tohooks.

It is contemplated that hooks or fasteners 324 and 332 are pre-connectedto annular member 326 during the manufacturing process at the factory.However, it is possible for one or more hooks 324 and/or 332 to beattached to annular member 326 in situ, as a step of the implantationprocedure. It is contemplated that the procedure of FIGS. 30-36 ispercutaneous. However, essentially the same procedure may be conductedvia open heart surgery in appropriate cases.

FIG. 37 shows two strands 346 and 348 of the tether 158 of FIG. 27extending between the inner margin or rim element 26 of scaffold 20 anda prosthetic valve 350. The procedure of FIGS. 22-27 represents one ofseveral ways of anchoring the subvalvular apparatus (cords or chordaetendineae 146 and papillary muscle 148) to the scaffold 20 and valve350. Tether 158 forms a noose 352 that is passed around cords 146. Thereare three kinds of cords: primary and secondary, which come off thepapillary muscles, and tertiary, which come off the wall 354 of the leftventricle. Noose 352 can capture at least most, if not all, of theprimary cords and probably most of the secondary cords. Strands orsegments 346 and 348 of tether 158 are placed under tension as valve 350is seated in orifice or neoannulus 28 and with echocardiographicmonitoring, the tension may be adjusted until the systolic shorteningcaused by the cords pull on scaffold 20.

As depicted in FIG. 38, a fastener 356 may be advanced over both strandsor segments 346 and 348 of tether 158 to secure the tether in positionrelative to the scaffold 20 and valve 350. Fastener 356 acts to compressor clamp the tether strands 346 and 348 at the site of contact withscaffold 20 or more particularly inner margin or rim element 26, actinglike a nut of a bolt, so that the fastener, by virtue of its size, holdsthe noose strands of segments 346 and 348 against the scaffold. Fastener356 may be coated with material that is blood compatible. Strands ortether segments 346 and 348 are severed at fastener 356 with anend-cutting device (not shown).

FIGS. 39-41 show a grappling hook device 358 that forms a particularembodiment of the fastening element 162 described hereinabove withreference to FIG. 29. Hook device 358 includes a stem 360 from whichemanate three prongs or fingers 362 each provided at a free end with ahook or barb 364. FIGS. 39-41 depict hook device 358 in an expanded useconfiguration wherein prongs or fingers 362 are each generally C-shapedand are disposed in respective planes (see FIG. 41) oriented at an angleof about 30° to 60° relative to each other. A tension member or tether366 is connected to stem 360.

Stem 360 and prongs or fingers 362 are made of a shape memory materialsuch as nitinol, so that hook device 358 may be delivered in a collapsedconfiguration to an atrial site through a small diameter catheter anddeployed through the orifice or neoannulus 28 of scaffold 20.

FIG. 42 shows grappling hook device 358 deployed so that barbs 364 atthe ends of prongs or fingers 262 engage the edges of mitral valveleaflet 144. Grappling hook 359 engages leaflet 144 and retracts it toorifice or neoannulus 28 (see FIG. 2). Whereas the method of FIGS.22-27, 37 and 38 transmits papillary forces by enveloping cords 146, theuse of grappling hook device 358 pulls on the leaflets 144, which inturn, capture the cords 146. The mechanism of incorporation of thetension member or tether 366 into the combined scaffold 20 and valve 350is identical to that described above with reference to FIGS. 22-27, 37and 38, except there is only one tension member 366 per hook device 358,as opposed to the two strands or tether segments 346 and 348 associatedwith noose 352. As depicted in FIG. 43, a fastener 368 is advanced overtension member 366 of each hook device 358 deployed and the tensionadjusted, then fixed. Tension member 366 is severed at fastener 368 withan end-cutting device (not shown). Fasteners 356 and 368 may be crimpedto ensure a tight locking engagement with strands or tether segments346, 348 or tether 366, respectively.

As an alternative to fastener 356 of FIG. 38, FIG. 45 depicts a spacermember 370 that separates and connects strands or tether segments 346and 348 associated with noose 352. Spacer member 370 is arc shaped, tofit snugly around cylindrically shaped valve 350 over a portion of innermargin or rim element 26. Strands or tether segments 346 and 348 aredisposed with one toward one end of leaflet 144 and the other toward anopposite end. The use of spacer member 370 has the benefit of notforeshortening the leaflet 144.

As illustrated in FIG. 46, outer margin or rim element 22 of scaffold 20may be attached to the heart wall 372 by means of a helical coil elementor cork screw 374 that advances into the heart wall upon a twisting of apositioning line 376 that is removably connected to a rear end of thecoil or cork screw element.

As shown in FIG. 47, outer margin or rim element 22 of scaffold 20 maybe attached to the heart wall 372 by means of a staple 378 that isadvanced over a positioning line or wire 380 and around margin or rimelement 22 so that leg ends 382 of the staple are inserted into theheart wall. Staple 378 is then pinched, for instance, by a tubularmember (not shown) inserted over positioning line or wire 380 and over arear end of the staple,

As depicted in FIG. 48, inner margin or rim element 26 of scaffold 20may take the form of an annular tubular member with an enclosed lumen(like a non-distensible inner-tube). This annular tubular member 26 isinserted in a collapsed configuration via the delivery catheter (orotherwise in an open heart procedure). After ejection of the scaffold 20from the distal end of the delivery catheter, the annular tubular memberis expanded from a collapsed configuration 384 to a donut (toroidal)shape as in FIG. 2 et seq. by infusion of a liquid through a tube 386communicating with the lumen of the tubular outer margin or rim element22. The tubular member is inflatable but not expandable (i.e., is madeof inelastic film material), so that valve 42 may be subsequentlyexpanded into orifice or neo-annulus opening 28. In one iteration orembodiment of this approach, if a particular expanded configuration isfound to be satisfactory, the inflation fluid could be replaced withanother fluid via tube 386 or another tube (not shown) that wouldcongeal into a solid or semi-solid, either by drainage and replacementwith a different liquid, or addition of a second liquid, which, whenmixed, caused the composite liquid to harden in the lumen and becomesolid or semi-solid.

The cross-section of the inflatable lumen described above may becircular, or possibly oval with a long axis 388 (FIG. 49) orientedperpendicularly to membranous portion 24 of scaffold 20, thus providinga more cylindrical configuration to the neo-annulus.

Additionally or alternatively, outer margin or rim element 22 ofscaffold 20 may take the form of an inflatable tubular member with anannular lumen inflatable by virtue of a removable tube 390 (FIG. 48), asdescribed above for the inner margin or neo-annulus rim element 26. Inthis instance, the material of the tubular member may be rigid, but morelikely semi-soft, allowing a tight fit with the heart wall. In thisiteration, it may be necessary to fix the outer margin 26 to the heartwall indirectly by through and through staples, hooks, or barbs 392(FIG. 49) at the adjacent edge of the membrane 24, rather than directlythrough the margin 26.

Alternatively, the lumen of the margin may contain a substance which ishydrophilic, such that it expands automatically when in contact withserum/blood/plasma. This may apply also to the neo-annulus.

As illustrated in FIG. 50, a delivery system for an implantable valvesupport device 610 comprises a delivery catheter 612, which contains theimplantable device in a collapsed low profile configuration tofacilitate minimally invasive access. FIG. 50 shows a plurality ofvalve-leaflet entrainment or capture elements 614 in the form of hooks,e.g., grappling hooks, or barbs. As illustrated in FIG. 51, each leafletentrainment element 614 is carried at the free or distal end of anelongate flexible tensile coupling element 616. Each tensile couplingelement 616 extends through a respective tubular positioning tether 618that is removably attached at its distal end to a locking element 620 inturn connected to a neo-annulus or scaffold 622 that receives andsupports a prosthetic or bio-prosthetic valve. Positioning tether 618surrounds a proximal portion 624 of tensile or tensile coupling member616. As discussed in detail hereinafter, in a prosthetic-valveimplantation procedure, neo-annulus or scaffold 622 is moved towards anative valve by exerting a distally directed force 626 on tubularpositioning tether 618 while exerting a proximally directed force 628 ontensile coupling element 616.

FIG. 52 shows delivery catheter 612 as advanced through a vascularsystem of a subject to a native heart valve HV having a pair of valveleaflets VL1 and VL2. A distal tip 630 of catheter 612 is located in orproximate to an orifice VO between valve leaflets VL1 and VL2. At thatjuncture of a valve implantation procedure, hook-like entrainment orcapture elements 614 and distal end portions of tensile couplingelements 16 are ejected from the distal tip 630 of delivery catheter612, as depicted in FIG. 53. Then, as shown in FIG. 54, deliverycatheter 612 is retracted back across the native heart valve HV with thehooks 614 and tension members 616 remaining in place.

FIG. 55 shows a subsequent step of a valve implantation procedure, inparticular a partial extrusion or ejection of neo-annulus or scaffold622 from delivery catheter 612. Hooks 614 and tensile coupling elements616 remain in place adjacent to the native valve leaflets VL1 and VL2.FIG. 56 shows neo-annulus or scaffold 622 fully ejected from catheter612 and expanded in the heart chamber or blood vessel. Multiplepositioning tethers 618 extend to respective locks 620 (FIG. 51) andsupport the expanded neo-annulus or scaffold 622 during the implantationprocedure. Tensile coupling elements 616 extend from respectivepositioning tethers 618 at the periphery of neo-annulus or scaffold 622.Leaflet-entrainment hooks 614 dangle loosely within or beyond the nativevalve orifice VO.

As shown in FIG. 56, the expanded neo-annulus or scaffold 622 takes theform of a ring which defines a valve-receiving circular orifice 623.Neo-annulus scaffold 622 is preferably flexible for at least a giventime after ejection from delivery catheter 612 so as to allowmanipulation and reconfiguration after delivery, but also relativelyinelastic so that a radially expanded valve 634 (FIG. 58 et seq.) doesnot distort it. Scaffold 622 may be constructed of a braided ormonofilament metal or other appropriate synthetic or naturally occurringmaterial with the appropriate physical characteristics. Alternatively,scaffold 622 made be made of nitinol optionally with atemperature-induced memory by which the scaffold assumes a substantiallyfixed ring shape after ejection from the delivery or deployment catheter612.

After the ejection of neo-annulus or scaffold 622, tensile couplingelements 616 are manipulated from outside the patient to bring hooks 614into engagement with the edges (not separately designated) of valveleaflets VL1 and VL2, as depicted in FIG. 57. This initial entrainmentallows normal or near normal valve function. Subsequently, as shown inFIG. 58, prosthetic or bio-prosthetic valve 634 is seated in neo-annulusorifice 623 and attached to scaffold 622 to form aneo-annulus/replacement valve complex 636.

FIG. 59 depicts scaffold 622 with the mounted valve 634 moved closer tonative valve HV. This change in position of neo-annulus/replacementvalve complex 636 is effectuated by pushing positioning tethers 618 in adistal direction, as indicated by force arrow 626 in FIG. 51, whilesimultaneously pulling tensile coupling elements 616 in a proximaldirection, as indicated by force arrow 628 in FIG. 51.

FIG. 60 is a schematic perspective view similar to FIG. 59, showingfurther advancement of neo-annulus/replacement valve complex 636 towardsthe orifice VO of the native valve HV. After a final advancement ofneo-annulus/replacement valve complex 636, depicted in FIG. 61, theneo-annulus/replacement valve complex is seated into the orifice VO ofthe native valve HV and tensile coupling elements are fully retracted tocurl the lips or edges of valve leaflets VL1 and VL2.

Subsequently, as depicted in FIG. 62, positioning tethers 618 areremoved or detached from the implanted neo-annulus/replacement valvecomplex 636 and tensile coupling elements 616 are severed at locks 620(FIG. 51). In the completed implantation, neo-annulus/replacement valvecomplex 636 is held by tensile coupling elements 616 and entrainmenthooks 614 in a fluid sealing engagement with valve leaflets VL1 and VL2.This mode of implantation ensures that the valve securing forces exertedby the chordae tendineae.

FIGS. 53-55 depict steps in a modified implantation procedure whereinneo-annulus or scaffold 622 is provided at spaced intervals around itscircumference with a plurality of flexible elongate tensile suspensionelements 638 that are attachable at their free ends 640 to a wall CVW ofthe heart or a blood vessel (collectively, “cardio-vascular wall”).Suspension members 638 are manipulated via respective deployment tethers642 that extend from delivery catheter 612 or a separate deploymentcatheter (not illustrated) and detachably attach to the suspensionmembers at free ends 640 thereof. Typically, free ends 640 of suspensionmembers 638 are coupled to wall CVW after the ejection of scaffold 622from catheter 612 but before the moving of neo-annulus/replacement valvecomplex 636 into engagement with valve leaflets VL1 and VL2, andpreferably before the seating of prosthetic valve 634 in orifice 623 ofneo-annulus or scaffold 622.

Scaffold 622 is optionally provided with suspension elements 638, whichare extendible radially to attach to the heart or blood vessel wall CVWnear the native valve HV for which replacement is intended. Suspensionelements 638 appear like spider legs, or as ring-topped, flattenedtripod (in an instance wherein three such elements are used). Suspensionelements 638 may be constructed of a spring-like material and are curvedto allow for fixation to heart or blood vessel wall CVW of variablecontour and also allow for excursion of the neo-annulus scaffold 622toward the valve HV as necessary.

FIG. 64 shows neo-annulus scaffold 622 supported by the deployedelongate suspension elements 638 of FIG. 63, and with deployment tethers642 removed. Scaffold 622 is ready for capture of valve leaflets LV1 andLV2 by entrainment hooks 614 and for deployment of prosthetic valve 634(not shown), followed by advancement of the complex 636 into the nativevalve orifice VO.

FIG. 65 depicts a detail of an alternative, auto-fixation, method ofattachment of a suspension line 638 to cardio-vascular wall CVW.Suspension line 638 is provided at a free end with a barb 644 thatanchors the suspension line to the cardiovascular wall CVW, barb 644being disposed in its entirety at the free end of line 638, oppositeneoannulus 622. Deployment tether 642 is removably coupled to suspensionline 638 to permit the forceful insertion of barb 644 into the tissuesof wall CVW at a point spaced from the native annulus and the subsequentdetachment of tether 642 from suspension line 638.

FIG. 66 is a schematic plan view of native mitral valve HV, showingvalve commissure gaps VC1 and VC2 between valve leaflets VL1 and VL2.FIG. 67 illustrates ring-shaped neo-annulus scaffold 622 in place overthe native mitral valve HV. Hooks 614 for capture of valve leaflets LV1and LV2 and the associated tensile coupling elements 616 are visiblethrough the orifice 623 of neo-annulus scaffold 622 while thepositioning tethers 618 of FIG. 100 extend from delivery catheter 612 tothe neo-annulus scaffold, the lumen 646 of the catheter being visible incross-section. As shown in FIGS. 19 and 20, with neo-annulus scaffold622 in position abutting the valve leaflets LV1 and LV2 and prostheticor bio-prosthetic replacement valve 634 deployed, commissure gaps VC1and VC2 are open at the periphery of the neo-annulus, resulting in aperivalvular leak. Two approaches for closing gaps VC1 and VC2 arediscussed below.

FIG. 69 also schematically illustrates locks 620 cooperating with thetensile coupling elements 616 to hold them in place relative toneo-annulus or scaffold 622.

FIG. 70 is a series of three side elevational views of a tissueapproximation clip or anchor 650 in three configurations relative toapposed valve leaflets LV1 and LV2. Clip or anchor 650 is initiallyinserted in a distal direction 652 through a commissure gap VC1 or VC2.Then clip or anchor 650 us retracted in a proximal direction 654,causing apposition of the leaflets and a closing of the gap. Finallyprongs 656 of clip or anchor 650 are bent downwardly at 658 forpermanent placement.

FIG. 71 is a partial schematic perspective view similar to FIG. 69,showing anchor-shaped clip 650 deployed for leaflet-edge approximation.Typically, one or more clips or anchors 650 are deployed after thelocking of neo-annulus/replacement valve complex 636 to the valveleaflets LV1 and LV2. However, one or more clips or anchors 650 mayalternatively deployed prior to the engagement or locking of theneo-annulus/replacement valve complex 636 to the valve leaflets.

In an alternative method for closing commisure gaps VC1 and VC2,neo-annulus or scaffold 622 is provided along an other periphery anouter circumferential side, facing away from the valve-receiving orifice(not shown), with a collapsed bladder-like component 660, as depicted inFIG. 72A. An inflation tube or port member 662 extends to collapsedbladder 660 for feeding thereto a fluid such as carbon dioxide, salinesolution, a liquid polymer, a polymerizable monomer composition, etc.,thereby expanding the collapsed bladder or balloon 660 to an enlargedconfiguration 664 shown in FIG. 72B. The expanded bladder configuration664 is also depicted in FIGS. 73 and 75, while FIG. 74 shows thecollapsed insertion configuration of balloon or bladder 660. As depictedin FIG. 75, expanded bladder configuration 664 covers and closes gapsVC1 and VC2 in cardiac tissue. Typically, as illustrated in FIGS. 74 and75, the bladder 660, 664 is an annular member extendingcircumferentially about the outer circumferential side of neo-annulus orscaffold 622 opposite the orifice so that the inflatable member 660, 664is spaced from the prosthetic or bio-prosthetic valve upon a seatingthereof in the orifice. Neoannulus or scaffold 622 has an innercircumferential side which faces toward the prosthetic or bio-prostheticvalve upon a seating thereof in the orifice of the main body member.

FIG. 76 is a schematic side elevational view of an incremental movementdevice in the form of ratchet-type locking components 620 and 666provided on the neo-annulus scaffold 622 and distal ends of tensilecoupling elements 616 to allow only one-way excursion of the tensilecoupling elements and the appended valve-capture or entrainment elements614 (see other figures). Locking component 666 is a series of taperedteeth 668 each having, for example, a frusto-conical form (FIG. 51). Inthat case, locking component 620 is a block provided internally with oneor more tapered passageway sections 670 that are geometrically congruentwith teeth 668. Tensile element 616 may be pulled in the proximaldirection 628 while positioning tether 618 is pushed in the distaldirection 626, which moves locking component 620, and accordinglyscaffold 622 and neo-annulus/replacement valve complex 636, in thedistal direction relative to tensile coupling element 616. However, theshapes of teeth 666 and passageway sections 670 prevent an oppositerelative motion of tensile coupling element 616 andneo-annulus/replacement valve complex 636. Ratchet-type lockingcomponents 620 and 666 thus enable a clamping of the neo-annulusscaffold 622 and attached replacement valve 634 to the valve leafletsLV1 and LV2.

FIGS. 77A and 77B show another embodiment of a ratchet mechanism whereinlock 620 is provided internally with a pivotably mounted latch ordétente 672 having a sharp end 674 pointed in a proximal direction,towards tether 618. Latch or détente 672 permits motion of tensilecoupling element 616 in the proximal direction 28, that is, towardstether 618 but prevents the opposite motion.

FIG. 78 depicts neo-annulus scaffold 622 with collapsed perimetralclosure bladder 660, tensile coupling elements 616 with distal hooks 614entrained to the ends or edges of native valve leaflets LV1 and LV2, andtubular tethers 618 extending from the distal end of a delivery catheter612 and holding the scaffold in position for installation.

FIG. 79 is a schematic perspective view similar to FIG. 78, showingreplacement valve 634 mounted to the neo-annulus scaffold 622.

FIG. 80 shows neo-annulus scaffold 622 in place above the native mitralvalve HV with native valve leaflets LV1 and LV2 captured and the “sewingring” or closure bladder 660 in its inflated configuration 664 but withthe replacement valve 634 omitted for clarity.

Suspension elements 638, as well as the neo-annulus or scaffold 622, maybe covered or coated with a substance to enhance tissue ingrowth,prevent clot or blood adhesion, may be drug eluting, heparin or othersubstance bonding, or or otherwise be constructed of a material thatenhances tissue ingrowth, prevent clot or blood adhesion.

The implantation device and associated method described above aredesigned in such a way as to enhance delivery by construction of thescaffold so that valve-capture elements 614, suspension elements 638, ifused, peri-valvular inflatable or gap-closure devices 650 and 660, ifused, are incorporated into the neo-annulus 622 such that serialemergence from the delivery system 612 simplifies placement of theentire system. Combining valve deployment with capture of the nativevalve leaflets LV1 and LV2 may create a minimal risk of valvularstenosis or insufficiency. Further, the design of the device transfersall cardiac forces onto the native valve HV. In the case of AV valves,the scaffold or valve support device 622 is at least indirectly securedto chordae tendineae, and therefore, the papillary muscles of the heart.Therefore such a device can distribute forces to the prosthetic valve634 similar to those typical of the normal, native valve.

FIG. 81 et seq. below describe alternative methods and devices forimplanting a prosthetic or bio-prosthetic valve in a heart chamber orblood vessel. Fastener or fixation devices 400, 428, and 436 describedhereinafter are useful for attaching suspension elements 438 tocardio-vascular wall CVW.

As illustrated in FIG. 81, a fastener or fixation device 400 forcoupling a valve-supporting scaffold 402 (FIGS. 87 and 88) comprises apair of helical prongs or legs 404 each attached at one end to a cap orhead 406 in the form of a disk. As illustrated in FIG. 83, disk 406 isprovided with a hole 408, which is traversed by a scaffold-positioningtether 410 (FIGS. 82, 83, 85) so that the fastener or fixation device400 is slidable along the tether. During a deployment operation, apusher member 412 in the form of an elongate sleeve or tube (only adistal end portion thereof shown in the figures) engages cap or head 406to press fastener 400 to a distal end of tether 410 and into organictissues, specifically a heart chamber or vessel wall 414. Once distaltips 416 of prongs or legs 404 enter the heart chamber or vessel wall414, further distal motion of pusher member 412 induces fastener to turnabout its longitudinal axis 418 (FIG. 81), twisting the fastener deeperinto the organic tissues. Prongs or legs 404 straddle an outer margin orouter rim element 420 (FIGS. 83-86) of scaffold 402, with one of theprongs or legs passing through a membrane 422 that extends betweenmargin 420 and an inner rim element or neo-annulus 424 of the scaffold.Prong tips 416 enter the heart or vessel wall on the opposing sides ofmargin 420, and the prongs or legs 404 cooperate with the organic tissuein a camming motion to induce rotation of the fastener 400.

Insertion of fastener 400 is complete when cap or head 406 comes intocontact with margin 420, as shown in FIG. 84. Pusher member 412 is thenwithdrawn (FIG. 85). Tether 410 is also detached from scaffold 402 andwithdrawn (FIG. 86). Pusher member 412 may be extracted from the heartor vessel and from the patient prior to the detachment and extraction oftether 410. Alternatively, tether 410 may be detached first (e.g., by atwisting of the tether), with a subsequent simultaneous extraction ofthe tether and pusher member 412.

FIG. 87 shows scaffold 402 after it has been ejected from a deliverycatheter 426 and opened from a collapsed insertion configuration (notshown) to the illustrated expanded deployment configuration. A pluralityof tethers 410, detachably linked at their distal ends to margin 420 ofscaffold 402 at spaced locations theralong, includes three primarytethers 410 a and optionally several secondary tethers 410 b. Primarytethers 410 a are manipulated to position margin 420 and concomitantlyscaffold 402 into a desired position and orientation inside a targetheart chamber or vessel. Fasteners 400 are initially deployed along theprimary tethers 410 a (see FIG. 88) to connect margin 420 to heartchamber or vessel wall 414 at three respective locations. Furtherfasteners 400 may be subsequently deployed along the secondary tethers410 b.

As depicted in FIGS. 89-91, an alternative fastener or margin fixationdevice 428 is a staple having two prongs or legs 430 each attached atone end to a cap or head 432 in the form of a perforated disk slidablytraversed by tether 410. Prongs or legs 430 each exhibit a shallowS-shape with an outwardly turned tip 434, the two prongs being mirrorimages of one another. Tips 434 cause prongs or legs 430 to splayoutwardly during an insertion operation, as shown in FIG. 91. Thisdivergence or opening of the staple prongs 430 serves to anchorfasteners 428 in a heart chamber or vessel wall 414.

As illustrated in FIGS. 92 and 93, another alternative fastener ormargin fixation device 436 is a staple having two prongs or legs 438each attached at one end to a cap or head 440 again in the form of aperforated disk slidably traversed by tether 410. Prongs or legs 438each have a slightly arcuate proximal portion 442 attached to cap orhead 440 and an inwardly dog-legged distal end 444. Distal ends 444cause prongs or legs 438 to crimp inwardly during an insertionoperation. As shown in FIG. 93, one or both prongs 438 may carry arearwardly oriented barb or hook 446 for providing enhanced resistanceto removal of the fastener 436 from the heart or vessel wall 414.

FIG. 94 depicts a valve retrieval system 448 comprising an introducercatheter 450 and a plurality of tethers 452 deployed via the catheterand provided at their free ends with capture hooks or barbs 454 forentraining leaflets 456 of a natural atrial valve 458 and indirectlycapturing the cords (not shown). Valve retrieval system 448 furtherincludes a tether guide member 460, which maintains tethers 452 in asuitably arranged or distributed array. To that end, tether guide membermay be provided with angularly spaced grooves or passageways for guidingthe respective tethers 452. Valve retrieval system 448 is inserted intothe patient after the installation of valve-supporting scaffold 402 andprior to the seating of a prosthetic valve 462 (FIGS. 101-103) inneo-annulus 424.

Upon an opening of the natural valve 458 as depicted in FIG. 95, valveretrieval system 448 is moved in a distal direction and inserted troughthe open valve, as depicted in FIG. 96. The natural valve then closesover valve retrieval system 448 as shown in FIG. 97. At that juncture,valve retrieval system 448 is slightly retracted so that the hooks orbarbs 454 are juxtaposed to the valve leaflets 456 as indicated in FIG.98. Tethers 452 and tether guide member 460 are then manipulated toinsert hooks or barbs 454 into valve leaflets 456. As indicated in FIG.99, the distal ends of tethers 452 including hooks or barbs 454 shiftlaterally or outwardly to capture and entrain leaflets 456. Thismovement of tethers 452 is implemented via tether guide member 460. Tothat end, the grooves or channels in tether guide member 460 that guidetethers 452 may be formed with camming surfaces such as humps that movethe tethers laterally outwardly upon a longitudinal shifting of theguide member 460 relative to the tethers.

After the ensnaring or snagging of leaflets 456 by hooks or barbs 454,catheter 450 and tether guide member 460 are withdrawn, as shown in FIG.100. Then, as depicted in FIG. 101, prosthetic valve 462 is insertedinside a ring of tethers 452 so that the leaflet-entraining tethers areclamped between neo-annulus 424 of scaffold 402 and the prostheticvalve. Tethers 452 are further retracted at that juncture to curlleaflets 456 and constrain them about the margin 420 of scaffold 402, asillustrated in FIG. 102. Then tethers 452 are severed (FIG. 102) andlocks 464 are attached to the severed tether ends (FIG. 103).

As illustrated in FIGS. 104 and 105, fastener 400 may be provided with apin 466 movably coupled to cap 406 for enabling a locking of thefastener to heart chamber or vessel wall 414. Upon completed insertionof prongs 404 into heart chamber or vessel wall 414, pin 466 is movedfrom a retracted neutral position (FIG. 104) to an advanced lockingposition (FIG. 105). In its advanced position, pin 466 prevents fastener400 from rotating or untwisting from its inserted position clampingmargin 420 to the heart or vessel wall.

FIG. 106 shows how delivery catheter 426 has a steerable distal end 468which may assume any of a plurality of orientations 468 a, 468 b, etc.relative to a main body 470 of the catheter, thereby facilitating aplacement of scaffold 402.

FIG. 107 depicts a distal end portion of a leaflet entrainment device472 having four hooks or barbs 474 that are actively or passivelyreleased when engaged with a valve leaflet or cord.

FIG. 108 depicts a leaflet entrainment device 476 with two subassemblies478 and 480 including respective tubular delivery members 482 and 484and pairs of hooks or barbs, 486 and 488. Tubular delivery members 482and 484 are spring biased to separate as illustrated after emergencefrom a delivery catheter 490.

FIGS. 109-113 depict a series of steps similar to those describedhereinabove with reference to FIGS. 94-103, applied in a retrogradeprocedure to capture leaflets 500 of an aortic valve 502 and attach thecaptured leaflets to an implanted scaffold 504 and a prosthetic valve506 which is seated in a neo-annulus 508 of the scaffold. The procedureof FIGS. 109-113 is particularly pertinent in solving a problem called“aortic insufficiency” where there is no calcium, so, like as in thecase of the mitral valve, an expanding, radial-force valve cannot beused. This disease is a common occurrence as a result of LVAD (leftventricular assist device) placement.

As shown in FIG. 109, a valve retrieval system 510 which is similar ifnot identical to system 448, comprises the same components, namely,introducer catheter 450 and tethers 452 with capture hooks or barbs 454at the free ends thereof. Hooks or barbs 454 are effective in theprocedure of FIGS. 109-113 to entrain leaflets 500 of aortic valve 502.Again, tether guide member 460 maintains tethers 452 in a suitablyarranged or distributed array. Valve retrieval system 448 is insertedinto the aorta after the installation of valve-supporting scaffold 502and prior to the seating of prosthetic valve 506 in neo-annulus 508.

Upon an opening of the aortic valve 502 as depicted in FIG. 109, valveretrieval system 448 is moved retrograde in the aorta (not separatelylabeled) and inserted through the open valve, as depicted. The aorticvalve 502 then closes over valve retrieval system 448 as shown in FIG.110. At that juncture, valve retrieval system 448 is slightly retractedso that the hooks or barbs 454 are juxtaposed to the valve leaflets 500as indicated in FIG. 111. Tethers 452 and tether guide member 460 arethen manipulated to insert hooks or barbs 454 into valve leaflets 500.As indicated in FIG. 112, the distal ends of tethers 452 including hooksor barbs 454 shift laterally or outwardly to capture and entrainleaflets 500. This movement of tethers 452 is implemented via tetherguide member 460, as described above with references to FIGS. 94-103.

After the ensnaring or snagging of aortic leaflets 500 by hooks or barbs454, catheter 450 and tether guide member 460 are withdrawn, prostheticvalve 506 is inserted inside a ring of tethers 452 so that theleaflet-entraining tethers are clamped between neo-annulus 508 ofscaffold 502 and the prosthetic valve. Tethers 452 are further retractedat that juncture to curl leaflets 456 and constrain them about themargin 512 of scaffold 502, as illustrated in FIG. 113. Then tethers 452are severed. Locks 464 may be attached to the severed tether ends, asdiscussed hereinabove with reference to FIG. 103.

In another approach constituting a variation of the procedure describedhereinabove with reference to FIGS. 1-30, a scaffold or valve supportdevice with a central orifice defining annulus and a preferably flexiblemargin or perimeter element is attached to the atrial wall. One thenwaits a few (3-6) weeks for tissue growth to bind the scaffold or valvesupport device to the atrial wall. At that juncture a prosthetic orbioprosthetic valve is seated in the orifice.

Accordingly, fastening elements are provided herein or in U.S. PatentApplication Publication No. 2010/0262232 and International PatentApplication No. PCT/US2010/001077 for attaching said scaffold or valvesupport device either (1) to heart or blood vessel tissue adjacent to anative heart valve, (2) at least indirectly to leaflets of a nativevalve of a patient, or (3) to both adjacent tissue and directly orindirectly to heart valve tissue. Preferably, the attachment is suchthat the scaffold or valve support device potentially is in effectiveforce-transmitting and effective perivalvular fluid-sealing contact withthe target native valve and substantially fixedly attached to thepatient.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. For instance, instead of being attached directly tothe valve leaflets VL1 and VL2, neo-annulus/replacement valve complex 36of suitable dimensions may be attached in whole or in part to thecardio-vascular wall CVW about native valve HV. Accordingly, it is to beunderstood that the drawings and descriptions herein are proffered byway of example to facilitate comprehension of the invention and shouldnot be construed to limit the scope thereof.

What is claimed is:
 1. An implantable device for use in valve placementin a subject, the device comprising: a main body member defining anorifice for receiving or seating a prosthetic or bio-prosthetic valve;at least one fastener connected at least indirectly to said main bodymember for attaching said main body member to leaflets of a nativevalve, said at least one fastener including an entrainment component andat least one elongate flexible tensile coupling element connected tosaid main body member and carrying said entrainment component at a freeend spaced from said main body member, said coupling element being ofsufficient length to extend, from said main body member spaced from thenative valve, through a natural opening of said native valve locatedbetween said valve leaflets; and a plurality of flexible elongatesuspension elements connected to said main body member at intervalsalong a circumference thereof, said flexible elongate suspensionelements being provided at respective free ends, opposite said main bodymember, with fasteners for attaching said main body member to acardio-vascular wall proximate to said native valve, said plurality offlexible elongate suspension elements being primary tether elements,further comprising a plurality of secondary tether elements extending todistal or free ends of said suspension elements for positioning saiddistal or free ends and fixing said distal or free ends to acardio-vascular wall proximate to said native valve.
 2. The device ofclaim 1 wherein said entrainment component is taken from the groupconsisting of a hook, clip, and barb for puncturing, capturing, orotherwise attaching to a valve leaflet or subvalvular structure of anative valve, said coupling element being one of a plurality of elongateflexible tensile coupling elements disposed at intervals around acircumference of said orifice, said coupling elements being configurableto attach said main body member to the valve leaflets of said nativevalve so that said main body member is in fluid-tight contact with saidvalve leaflets and substantially fixedly attached thereto, furthercomprising a system of tether elements removably connected to said mainbody member for manipulating, positioning, and fixating of said mainbody member to the native valve.
 3. The device of claim 2, furthercomprising at least one leakage-control element different from said mainbody member, said coupling elements and said entrainment components andconnected to said main body member for closing a gap between adjacentones of said valve leaflets, thereby at least reducing peri-valvularleakage, if necessary.
 4. The device of claim 3 wherein said at leastone leakage-control element is taken from the group consisting of (a) aflexible expandable balloon member mounted to said main body member andan inflation tube connected to said expandable member for delivering afluid thereto and (b) an approximation clip having at least two prongsor legs.
 5. The device of claim 2 wherein said coupling elements aredistal end portions of respective elongate tensile members havingproximal end portions removably coupled to said distal end portions. 6.The device of claim 5, wherein said tether elements are in the form ofelongate tubular members or sleeves each surrounding a respective one ofsaid proximal end portions and in operative or effective engagement at adistal end with said main body member for pushing said main body memberin a distal direction relative to said distal end portions of saidtensile members, whereby said main body member is movable intoengagement with the valve leaflets of said native valve.
 7. The deviceof claim 2 wherein said coupling elements are movably attached to saidmain body member initially for motion alternately in a distal directionand a proximal direction relative to said main body member.
 8. Thedevice of claim 7 wherein said tether elements are tubular and coaxiallysurround proximal end portions of said coupling elements, said tetherelements being incrementally advanceable in concert with a proximallydirected retraction force exertable on said coupling elements, to inducesaid main body member and captured native valve leaflets to move towardsand into contact with each other.
 9. The device of claim 1 wherein: saidsecondary tether elements can each be used to deliver an additionalfastener which contains an orifice allowing the additional fastener tobe advanced over or around the respective one of said secondary tetherelements; and each said secondary tether element being provided with asurrounding sleeve, or other advanceable component, slidably movablerelative to the respective secondary tether element for advancing therespective additional fastener, distal ends of said secondary tetherelements being removably attached to said distal or free ends of saidsuspension elements.
 10. An implantable device for use in valveplacement in a subject, the device comprising: a main body memberdefining an orifice for receiving or seating a prosthetic orbio-prosthetic valve; and at least one fastener connected at leastindirectly to said main body member for attaching said main body memberto leaflets of a native valve, said at least one fastener including anentrainment component and at least one elongate flexible tensilecoupling element connected to said main body member and carrying saidentrainment component at an end spaced from said main body member, saidcoupling element being of sufficient length to extend, from said mainbody member spaced from the native valve, through a natural opening ofsaid native valve located between said valve leaflets, said couplingelements being movably attached to said main body member initially formotion alternately in a distal direction and a proximal directionrelative to said main body member, wherein said coupling elements andsaid main body member are provided with cooperating ratchet componentsfor preventing the hooks, barbs, or other entrainment components at thedistal ends of said coupling elements from moving away from said mainbody member once said main body member is advanced a predetermineddistance over said coupling elements towards the hooks, barbs, or otherentrainment components, whereby said main body member is locked intoposition and cannot be separated from said valve leaflets uponengagement of said main body member with the valve leaflets.
 11. Animplantable device for use in valve placement in a subject, the devicecomprising: a main body member defining an orifice for receiving orseating a prosthetic or bio-prosthetic valve; a plurality of flexibleelongate suspension elements each connected at a first end of twoopposing ends to said main body member at intervals along acircumference thereof; and a plurality of fasteners each disposed at asecond end of a respective one of said flexible elongate suspensionelements, opposite said main body member and spaced in their entiretytherefrom, for attaching said main body member to a cardio-vascular wallspaced from an annulus of said native valve via said flexible elongatesuspension elements, wherein said flexible elongate suspension elementsare primary tether elements, further comprising a plurality of secondarytether elements extending to said second ends of said primary tetherelements for positioning said second ends and fixing said second endsvia said fasteners to a cardio vascular wall spaced from the annulus ofsaid native valve.
 12. The device of claim 11 wherein said secondarytether elements are removably appended at distal ends to said distal orfree ends of said primary tether elements.
 13. The device of claim 11wherein said secondary tether elements extend from a deploymentcatheter.